10-Q: Quarterly report pursuant to Section 13 or 15(d)
Published on May 11, 2022
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) |
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(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 |
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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 May 5, 2022, there were
VOLITIONRX LIMITED
QUARTERLY REPORT ON FORM 10-Q
FOR THE THREE MONTHS ENDED MARCH 31, 2022
TABLE OF CONTENTS
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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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.
| 2 |
| Table Of Contents |
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
This Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, or this Report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact included in this Report or incorporated by reference into this Report are forward-looking statements. These statements include, among other things, predictions of earnings, revenues, expenses or other financial items; plans or expectations with respect to our development activities or business strategy; statements concerning clinical studies and results; statements concerning industry trends; statements regarding anticipated demand for our products, or the products of our competitors; statements relating to manufacturing forecasts, and the potential impact of our relationship with contract manufacturers and original equipment manufacturers on our business; statements relating to the commercialization of our products, assumptions regarding the future cost and potential benefits of our research and development efforts; forecasts of our liquidity position or available cash resources; statements relating to the impact of pending litigation; statements regarding the anticipated impact of the COVID-19 pandemic and statements relating to the assumptions underlying any of the foregoing. Throughout this Report, we have attempted to identify forward-looking statements by using words such as “may,” “believe,” “will,” “could,” “project,” “anticipate,” “expect,” “estimate,” “should,” “continue,” “potential,” “plan,” “forecasts,” “goal,” “seek,” “intend,” other forms of these words or similar words or expressions or the negative thereof (although not all forward-looking statements contain these words).
We have based our forward-looking statements on our current expectations and projections about trends affecting our business and industry and other future events. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Forward-looking statements are subject to substantial risks and uncertainties that could cause our future business, financial condition, results of operations or performance, to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this Report.
Some significant factors that may impact our estimates and forward-looking statements include, but are not limited to:
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Our inability to generate any significant revenue or achieve profitability; |
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Our need to raise additional capital in the future; |
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Our expectations to expand our product development, research and sales and marketing capabilities could give rise to difficulties in managing our growth; |
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Our limited experience with direct sales and marketing; |
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The material weaknesses in our internal control over financial reporting that we have identified; |
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The possibility that we may not be able to continue to operate, as indicated by the “going concern” opinion from our auditors; |
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Our ability to successfully develop, manufacture, market, and sell our future products; |
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Our ability to timely obtain necessary regulatory clearances or approvals to distribute and market our future products; |
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The acceptance by the marketplace of our future products; |
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The highly competitive and rapidly changing nature of the cancer diagnostics market; |
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Our reliance on third parties to manufacture and supply our intended products, and such manufacturers’ dependence on third-party suppliers; |
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Our dependence on third-party distributors; |
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Protection of our patents, intellectual property and trade secrets; |
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Business disruptions and economic and other uncertainties surrounding the COVID-19 pandemic; 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, 2021, as filed with the SEC on March 30, 2022, or our Annual Report, this Report, the documents that we file as exhibits to this Report and the documents that we incorporate by reference into this Report, with the understanding that our future results may be materially different from what we currently expect. The forward-looking statements we make speak only as of the date on which they are made. We expressly disclaim any intent or obligation to update any forward-looking statements after the date hereof to conform such statements to actual results or to changes in our opinions or expectations. If we do update or correct any forward-looking statements, readers should not conclude that we will make additional updates or corrections.
3 |
| Table Of Contents |
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PART I FINANCIAL INFORMATION
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ITEM 1. FINANCIAL STATEMENTS (UNAUDITED) |
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Page |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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| 4 |
| Table Of Contents |
VOLITIONRX LIMITED
Condensed Consolidated Balance Sheets
(Expressed in United States Dollars, except share numbers)
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March 31, |
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December 31, |
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2022 |
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2021 |
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$ |
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$ |
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ASSETS |
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(UNAUDITED) |
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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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Deferred revenue |
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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: |
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Issued and outstanding: |
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Additional paid-in capital |
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Accumulated other comprehensive income |
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Accumulated deficit |
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( |
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( |
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Total VolitionRx Limited Stockholders’ Equity |
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Non-controlling interest |
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( |
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( |
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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) | ||||||||
| 5 |
| 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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Three Months Ended March 31, |
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2022 |
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2021 |
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$ |
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$ |
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Revenues |
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Services |
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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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( |
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( |
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Other Income (Expenses) |
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Interest income |
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Interest expense |
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( |
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( |
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Total Other Income (Expenses) |
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(41,030 | ) |
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(40,460 | ) |
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Net Loss |
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( |
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( |
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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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( |
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( |
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Other Comprehensive (Loss) / Income |
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Foreign currency translation adjustments |
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( |
) |
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Net Comprehensive Loss |
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( |
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( |
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Net Loss Per Share – Basic and Diluted |
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( |
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( |
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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)
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Accumulated |
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Additional |
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Other |
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Non |
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Common Stock |
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Paid-in |
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Comprehensive |
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Accumulated |
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Controlling |
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Shares |
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Amount |
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Capital |
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Income (Loss) |
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Deficit |
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Interest |
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Total |
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# |
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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Balance, December 31, 2021 |
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( |
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( |
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Common stock issued for cash |
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Common stock issued for settlement of RSUs |
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( |
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Stock-based compensation |
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- |
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Foreign currency translation |
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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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- |
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( |
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( |
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( |
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Balance, March 31, 2022 |
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( |
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Balance, December 31, 2020 |
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( |
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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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( |
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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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( |
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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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( |
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( |
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Balance, March 31, 2021 |
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( |
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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 Cash Flows (Unaudited)
(Expressed in United States Dollars)
|
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Three Months Ended March 31, |
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2022 |
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2021 |
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$ |
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$ |
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Operating Activities |
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Net Loss |
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( |
) |
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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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Stock-based compensation |
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Changes in operating assets and liabilities: |
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Prepaid expenses |
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( |
) |
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( |
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Accounts receivable |
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( |
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( |
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Other current assets |
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( |
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Deferred Revenue, current and non-current |
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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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( |
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Net Cash Provided By / (Used In) Operating Activities |
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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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( |
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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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Proceeds from long-term debt |
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Payments on long-term debt |
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( |
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( |
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Payments on finance lease obligations |
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( |
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( |
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Net Cash Provided By Financing Activities |
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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 and settlement of vested RSUs |
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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) | ||||||||
| 8 |
| Table Of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 1 – Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company also regularly evaluates estimates and assumptions related to deferred income tax asset valuation allowances, useful lives of property and equipment and intangible assets, borrowing rate used in operating lease right-of-use asset and liability valuations, impairment analysis of intangible assets, and valuations of stock-based compensation.
The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from the Company’s estimates. To the extent there are material differences between the estimates and the actual results, future results of operations could be affected.
Principles of Consolidation
The accompanying condensed consolidated financial statements for the period ended March 31, 2022 include the accounts of the Company and its subsidiaries. The Company has two wholly-owned subsidiaries Singapore Volition Pte. Limited (“Singapore Volition”) and Volition Global Services SRL (“Volition Global”). Singapore Volition has one wholly-owned subsidiary, Belgian Volition SRL (“Belgian Volition”). Belgian Volition has four subsidiaries, Volition Diagnostics UK Limited (“Volition Diagnostics”), Volition America, Inc. (“Volition America”), Volition Germany GmbH (“Volition Germany”), and its one majority-owned subsidiary Volition Veterinary Diagnostics Development LLC (“Volition Vet”). See Note 8(f) for more information regarding Volition Vet, Volition Germany and Volition America. All intercompany balances and transactions have been eliminated in consolidation.
Cash and Cash Equivalents
| 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 (continued)
Accounts Receivables
Revenue Recognition
The Company adopted Accounting Standards Codification (“ASC”)606, “Revenue from Contracts with Customers,” effective January 1, 2019. Under ASC 606, the Company recognizes revenues when the customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. The Company recognizes revenues following the five step model prescribed under ASC 606: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation(s).
The Company generates product revenues from the sale of its Nu.Q® Vet Cancer Screening Test, from the sale of nucleosomes, and from the sale of Research Use Only kits. In addition, revenue is received from external third parties for Nu.Q® Discover services the Company performs for them in its laboratory.
Revenues, and their respective treatment for financial reporting purposes under ASC 606, are as follows:
Royalty
The Company receives royalty revenues on the net sales recognized during the period in which the revenue is earned, and the amount is determinable from the licensee. These are presented in “Royalty” in the consolidated statements of operations and comprehensive loss. The Company does not have future performance obligations under this revenue stream. In accordance with ASC 606, the Company records these revenues based on estimates of the net sales that occurred during the relevant period from the licensee. The relevant period estimates of these royalties are based on preliminary gross sales data provided by Customers and analysis of historical gross-to-net adjustments. Differences between actual and estimated royalty revenues are adjusted for in the period in which they become known.
Product
The Company includes revenue from product sales recognized during the period in which goods are shipped to third parties, and the amount is deemed collectable from the third parties. These are presented in “Product” in the consolidated statements of operations and comprehensive loss.
| 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)
Services
The Company includes revenue recognized from laboratory services performed in the Company’s laboratory on behalf of third parties in “Services” in the consolidated statements of operations and comprehensive loss.
For each development and/or commercialization agreement that results in revenues, the Company identifies all performance obligations, aside from those that are immaterial, which may include a license to intellectual property and know-how, development activities and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.
Licensing
The Company includes revenue recognized from the licensing of certain rights to third parties in “Licensing” in the consolidated statements of operations. For each development and/or commercialization agreement that results in revenues, the Company identifies all performance obligations, aside from those that are immaterial, which may include a license to intellectual property and know-how, development activities and/or transition activities. In order to determine the transaction price, in addition to any upfront payment, the Company estimates the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. The Company constrains (reduces) the estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, management considers whether there are factors outside the Company’s control that could result in a significant reversal of revenue. In making these assessments, the Company considers the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.
Deferred Revenue (Contract Liabilities) and Contract Assets
Contract assets include costs and services incurred on contracts with open performance obligations. These contract assets were immaterial as of March 31, 2022.
Basic and Diluted Net Loss Per Share
| 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)
Foreign Currency Translation
The Company has functional currencies in Euros, US Dollars and British Pounds Sterling and its reporting currency is the US Dollar. Management has adopted ASC 830-20, “Foreign Currency Matters – Foreign Currency Transactions”. All assets and liabilities denominated in foreign currencies are translated using the exchange rate prevailing at the balance sheet date. For revenues and expenses, the weighted average exchange rate for the period is used. Gains and losses arising on translation of foreign currency denominated transactions are included in other comprehensive income (loss).
Research and Development
Stock-Based Compensation
The Company records stock-based compensation in accordance with ASC 718, “Compensation – Stock Compensation”. Under the provisions of ASC 718, stock-based compensation cost is measured at the grant date, based on the fair value of the award, and is recognized over the employee’s requisite service period, which is generally the vesting period. The fair value of our stock options and warrants is estimated using a Black-Scholes option valuation model. Restricted stock units are valued based on the closing stock price on the date of grant. Refer to Note 7 for further details.
Reclassification
Certain amounts presented in previously issued financial statements have been reclassified to be consistent with the current period presentation. The Company has reclassified the prior period comparative amounts in Part I, Item 2. “MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS” of the Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, in relation to Research and Development expenses, General and Administrative expenses and Sales and Marketing expenses to be consistent with the current year classification.
Recent Accounting Pronouncements
The Company has implemented all new accounting pronouncements that are in effect. The Company does not believe there are any other new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.
COVID-19 Pandemic Impact
As of the date of this filing, there continue to be widespread concerns regarding the ongoing impacts and disruptions caused by the COVID-19 pandemic in the regions in which the Company operates. As a result of the COVID-19 pandemic, the Company has experienced and may continue to experience disruptions that could impact our clinical trials, including delays enrolling patients and in sample collection.
The extent to which the COVID-19 pandemic will impact the Company’s business, financial condition, and results of operations in the future is highly uncertain and will be affected by a number of factors. These include the duration and extent of the COVID-19 pandemic, the development of new variants of the COVID-19 virus that may be more contagious or virulent than previous versions, the scope of mandated or recommended containment and mitigation measures, the effect of government stabilization and recovery efforts, and the success of vaccine distribution programs.
| 12 |
| Table Of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 2 - Going Concern
The Company’s condensed consolidated financial statements are prepared using U.S. GAAP applicable to a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company has incurred losses since inception of $
The future of the Company as an operating business will depend on its ability to obtain sufficient capital contributions, financing and/or to generate revenues as may be required to sustain its operations. Management plans to address the above as needed by (a) securing additional grant funds, (b) obtaining additional financing through debt or equity transactions, (c) granting licenses to third parties in exchange for specified up-front and/or milestone payments and (d) developing and commercializing its products on an accelerated timeline. Management continues to exercise tight cost controls to conserve cash.
The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraph and eventually attain profitable operations. The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern. If the Company is unable to obtain adequate capital, it could be forced to cease operations.
| 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 March 31, 2022 and December 31, 2021:
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March 31, |
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2022 |
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Accumulated |
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Net Carrying |
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Depreciation |
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Value |
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Useful Life |
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$ |
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$ |
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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 |
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Not amortized |
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December 31, |
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2021 |
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Accumulated |
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Net Carrying |
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Cost |
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Depreciation |
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Value |
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Useful Life |
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$ |
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$ |
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$ |
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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 |
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Not amortized |
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During the three-month periods ended March 31, 2022 and March 31, 2021, 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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March 31, |
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2022 |
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Accumulated |
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Net Carrying |
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Cost |
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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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2021 |
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Accumulated |
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Net Carrying |
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Cost |
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Amortization |
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Value |
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$ |
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$ |
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Patents |
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During the three-month periods ended March 31, 2022 and March 31, 2021, the Company recognized $
The Company amortizes the patents on a straight-line basis with terms ranging from
2022 |
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$ |
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2023 |
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$ |
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2024 |
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$ |
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Total Intangible Assets |
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$ |
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The Company periodically reviews its long-lived assets to ensure that their carrying value does not exceed their fair market value. The Company carried out such a review in accordance with ASC 360 Topic “Property, Plant and Equipment” as of December 31, 2021. The result of this review confirmed that the ongoing value of the patents was not impaired as of December 31, 2021.
Note 5 - Related Party Transactions
See Note 6, Common Stock, for common stock issued to related parties and Note 7, Stock-Based Compensation, for stock options, warrants and RSUs issued to related parties. The Company has agreements with related parties for the purchase of products and consultancy services which are accrued under management and directors’ fees payable (see condensed consolidated balance sheets).
| 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 March 31, 2022, the Company was authorized to issue
Stock Option Exercises and RSU Settlements
On March 28, 2022,
Equity Distribution Agreement
On September 24, 2021, the Company entered into an equity distribution agreement (the “2021 EDA”) with Cantor Fitzgerald & Co. Inc. (“Cantor”)and Oppenheimer & Co. Inc. (“Oppenheimer”), to sell shares of its common stock having an aggregate offering price of up to $
Note 7 – Stock-Based Compensation
a) Warrants
The following table summarizes the changes in warrants outstanding of the Company during the three-month period ended March 31, 2022:
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Weighted Average |
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Number of Warrants |
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Exercise Price ($) |
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Outstanding at December 31, 2021 |
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Granted |
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- |
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Outstanding at March 31, 2022 |
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Exercisable at March 31, 2022 |
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Below is a table summarizing the warrants issued and outstanding as of March 31, 2022, which have an aggregate weighted average remaining contractual life of
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Weighted Average |
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| 16 |
| Table Of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ 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 three-month period ended March 31, 2022:
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Weighted Average |
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Number of Options |
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Exercise Price ($) |
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Outstanding at December 31, 2021 |
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Granted |
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- |
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Exercised |
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- |
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Expired/Cancelled |
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Outstanding at March 31, 2022 |
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Exercisable at March 31, 2022 |
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.
Below is a table summarizing the options issued and outstanding as of March 31, 2022, all of which were issued pursuant to the 2011 Equity Incentive Plan (for option issuances prior to 2016) or the 2015 Stock Incentive Plan (for option issuances commencing in 2016) and which have an aggregate weighted average remaining contractual life of
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Weighted Average |
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Remaining |
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Proceeds to |
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Exercise |
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Contractual |
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Company if |
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Outstanding |
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Exercisable |
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Price ($) |
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Exercised ($) |
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| 17 |
| Table Of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-Based Compensation (continued)
b) Options (continued)
Stock-based compensation expense related to stock options of $
c) Restricted Stock Units (RSUs)
Below is a table summarizing the RSUs issued and outstanding as of March 31, 2022, all of which were issued pursuant to the 2015 Stock Incentive Plan.
|
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Number of |
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Weighted Average |
|
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|
|
RSUs |
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Share Price ($) |
|
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Outstanding at December 31, 2021 |
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Granted |
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Vested/Settled |
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(15,000 | ) |
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Cancelled |
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- |
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Outstanding at March 31, 2022 |
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Effective February 8, 2022, the Company granted aggregate RSUs of
Effective March 1, 2022, the Company granted aggregate RSUs of
On March 28, 2022,
| 18 |
| Table Of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-based Compensation (continued)
c) Restricted Stock Units (RSUs) (continued)
Below is a table summarizing the RSUs issued and outstanding as of March 31, 2022 and which have an aggregate weighted average remaining contractual life of
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Weighted |
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Average |
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Contractual |
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Price ($) |
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Stock-based compensation expense related to RSUs of $
| 19 |
| Table Of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies
a) Finance Lease Obligations
In 2016, the Company entered into a capital lease with ING Asset Finance Belgium S.A. (“ING”) to purchase a property located in Belgium for €
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 March 31, 2022.
2022 |
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$ |
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2023 |
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$ |
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2024 |
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$ |
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2025 |
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$ |
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2026 |
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$ |
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Greater than 5 years |
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$ |
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Total |
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$ |
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Less: Amount representing interest |
|
$ | ( |
) |
Present value of minimum lease payments |
|
$ |
|
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
During the three months ended March 31, 2022, the Company entered into a new lease agreement. The lease is initially for 62 months and the initial rent is $
As of March 31, 2022, operating lease right-of-use assets and liabilities arising from operating leases were $
| 20 |
| Table Of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies
b) Operating Lease Right-of-Use Obligations (continued)
The following is a schedule showing the future minimum lease payments under operating leases by years and the present value of the minimum payments as of March 31, 2022.
2022 |
|
$ |
|
|
2023 |
|
$ |
|
|
2024 |
|
$ |
|
|
2025 |
|
$ |
|
|
2026 |
|
$ |
|
|
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 three months ended March 31, 2022, the Company recognized $
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 €
In 2018, the Company entered into an agreement with the Walloon Region government in Belgium for a colorectal cancer research grant for €
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 €
| 21 |
| Table Of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
c) Grants Repayable (continued)
As of March 31, 2022, the total grant balance repayable was $
2022 |
|
$ |
|
|
2023 |
|
$ |
|
|
2024 |
|
$ |
|
|
2025 |
|
$ |
|
|
2026 |
|
$ |
|
|
Greater than 5 years |
|
$ |
|
|
Total Grants Repayable |
|
$ |
|
d) Long-Term Debt
In 2016, the Company entered into a
In 2016, the Company entered into a
In 2017, the Company entered into a
In 2018, the Company entered into a
In 2019, the Company entered into a
On October 13, 2020, the Company entered into a
On November 23, 2021, the Company entered into a 3 ½ year loan agreement with SOFINEX for a maximum of €
On February 5, 2022, the Company entered into a
| 22 |
| Table Of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
d) Long-Term Debt (continued)
As of March 31, 2022, the total balance for long-term debt payable was $
2022 |
|
$ |
|
|
2023 |
|
$ |
|
|
2024 |
|
$ |
|
|
2025 |
|
$ |
|
|
2026 |
|
$ |
|
|
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
In 2018, the Company entered into a research collaboration agreement with the University of Taiwan for a
In 2019, the
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 March 31, 2022, the total amount to be paid for future research and collaboration commitments was approximately $
2022 - remaining |
|
$ |
|
|
2022 - 2026 |
|
$ |
|
|
Total Collaborative Agreement Obligations |
|
$ |
|
| 23 |
| Table Of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
f) Other Commitments
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 €
The Company recorded approximately $
| 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)
f) Other Commitments (Continued)
Volition America
On November 3, 2020, the Company entered into a professional services master agreement with Diagnostic Oncology CRO, LLC to conduct a pivotal clinical trial and provide regulatory submission and reimbursement related services. Under the terms of the agreement Diagnostic Oncology CRO, LLC will provide ad hoc consulting assistance on a project-by-project basis related to the review and assessment of existing data and information to prepare recommended intended use claims and coverage/reimbursement plans to support the preparation of FDA pre-submissions, clinical trial protocol development and study administration, and potential 510k regulatory marketing submissions of the Company’s diagnostic tests, including those proposed for use as an adjunct diagnostic tool for common and aggressive forms of Non-Hodgkin’s Lymphoma. The initial projects contemplated by the agreement relating to Non-Hodgkin’s Lymphoma obligate
g) Legal Proceedings
There are no legal proceedings which the Company believes will have a material adverse effect on its financial position.
h) Commitments in Respect of Corporate Goals and Performance-Based Awards
In August 2021 and October 2021 the Compensation Committee of the Board of Directors approved the granting of equity-based awards under the 2015 Stock Incentive Plan as well as cash bonuses, vesting upon achievement of certain corporate goals focused around product development and commercialization, to various personnel including directors, executives, members of management, consultants and employees of the Company and/or its subsidiaries.
Conditional upon the achievement by July 1, 2022 of all specified corporate goals as set forth in the minutes of the Compensation Committee, as well as continued service by the award recipient, the Company at the sole discretion of the Chief Executive Officer and the Chief Financial Officer would pay a cash bonus to such award recipient. The Company estimates the total compensation expense based on current recipients to be $
As discussed in detail in Note 8 - Stock-Based Compensation, of the notes to consolidated financial statements contained in the Annual Report on Form 10-K for the year ended December 31, 2021, an aggregate of
As of March 31, 2022, the Company has recognized compensation expense of $
| 25 |
| Table Of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 9 – Subsequent Events
RSU and Warrant Grants
Effective April 4, 2022, the Company granted RSUs of
Effective April 4, 2022, the Company granted RSUs of
Effective April 4, 2022, the Company granted a warrant to purchase
Subsequent to March 31, 2022,
Equity Distribution Agreements
Termination of Equity Distribution Agreement
Effective May 7, 2022, the Company terminated its 2021 EDA and no further sales of the Company’s common stock will be made under the 2021 EDA. From April 1, 2022 to May 7, 2022, the Company made no additional sales under the 2021 EDA.
END NOTES TO FINANCIALS
| 26 |
| 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.
Overview
Volition is a multi-national epigenetics company that applies its Nucleosomics™ platform through its subsidiaries to develop simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including certain cancers and diseases associated with NETosis such as sepsis and COVID-19. Our mission is to save lives and improve outcomes for millions of people and animals worldwide. Early diagnosis and monitoring have the potential to not only prolong the life of patients, but also to improve their quality of life.
Our blood tests are based on the science of Nucleosomics™, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid-an indication that disease is present. We are primarily focused on human diagnostics and monitoring but also have a subsidiary focused on animal diagnostics and monitoring.
We have five key pillars of focus, all of which use the same proprietary Nu.Q® platform to commercialize in different areas.
|
· |
Nu.Q® Vet - cost-effective, easy-to-use cancer screening blood test for dogs and other animals |
|
· |
Nu.Q® NETs - monitoring the immune system to save lives |
|
· |
Nu.Q® - detecting cancer early to save lives |
|
· |
Nu.Q® Capture - capturing and concentrating samples for more accurate diagnosis |
|
· |
Nu.Q® Discover - a complete solution to profiling nucleosomes |
Our research and development activities are centered in Belgium, with an innovation laboratory in California, and additional offices in Texas, London, and Singapore, where we focus on bringing our diagnostic and disease monitoring products to market.
Commercialization Strategy
We believe, given the global prevalence of cancer and diseases associated with NETosis, and the low-cost, accessible and routine nature of our tests, Nu.Q® could potentially be used throughout the world.
We have developed and are continuing to develop a large portfolio of intellectual property (“IP”), centered around the science of identifying and measuring nucleosomes in the bloodstream. We call this science Nucleosomics™. Our technologies have a large range of applications, both in humans and animals, to screen, diagnose, and risk stratify patients, as well as to monitor treatments, disease progression and potential remissions. While we initially focused on screening for cancer, we have broadened the range of indications our blood tests can detect to include several diseases associated with NETosis, including sepsis and COVID-19, which is estimated to be responsible for one in five deaths worldwide.
We aim to remain an IP powerhouse in the Nucleosomics™ space and expect to monetize our IP and technologies through licensing and distribution contracts with companies with established distribution networks on a worldwide or regional basis, in both human and animal care.
To this end, on March 28, 2022, Volition entered into a license and product supply agreement with Heska Corporation, a leading global provider of advanced veterinary diagnostics. In exchange for granting Heska Corporation exclusive worldwide rights to sell the Nu.Q® Vet Cancer Test at the point of care for companion animals, Volition received a $10 million upfront payment on signing and is eligible to receive up to an additional $18 million based upon the achievement of near and mid-term milestones. In addition, Volition has granted Heska non-exclusive rights to sell the Nu.Q® Vet Cancer Screening Test in kit format for companion animals, through Heska’s network of central reference laboratories.
| 27 |
| Table Of Contents |
Following the roll-out of our Nu.Q® Vet canine cancer screening test and Nu.Q® Discover, the next series of products we anticipate launching are as follows:
|
· |
a canine cancer monitoring test; |
|
· |
NETosis related screening and monitoring tests for use in sepsis and COVID-19; |
|
· |
cancer tests for humans in Non-Hodgkin’s Lymphoma, colorectal cancer and lung cancer. |
Our Nucleosomics™ technology is transferable to multiple platforms including ELISA 96-well plates and, bead-based chemiluminescent and we are currently working on transferring our technology to the widely-utilized homogeneous immunoassay, or HIA, platform and several point of care platforms to enable rapid turnaround of results in–clinic and in the doctor’s office.
Additionally, we are working on complete nucleosome analysis with our Nu.Q® Capture technology. The goal of this project is to investigate ways to specifically target circulating tumor DNA (“ctDNA”). The ability to enrich ctDNA will allow us to use mass spectrometry to analyze histone and DNA modifications, and to sequence DNA present around nucleosomes. This information could enable cancer diagnosis to identify the tissue of origin of a particular cancer.
Developments - COVID-19 Pandemic
Since the beginning of the COVID-19 pandemic in March 2020, we have implemented contingency planning to protect the health and well-being of our employees and to mitigate the impacts of the pandemic on our business. We have implemented travel restrictions as well as protocols limiting visitor access to our facilities, and we are following social distancing practices. As a result of the COVID-19 pandemic, we have experienced and may continue to experience disruptions that could impact our clinical trials, including:
|
· |
delays in enrolling patients in clinical trials; |
|
· |
delays in sample collection; and |
|
· |
diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as clinical trial sites and hospital staff supporting the conduct of our clinical trials. |
The extent to which the COVID-19 pandemic will impact our business, financial condition, and results of operations in the future remains uncertain and will be affected by a number of factors outside of our control, including the duration and extent of the pandemic, the development of new variants of the COVID-19 virus that may be more contagious or virulent than previous versions, the scope of mandated or recommended containment and mitigation measures, the effect of government stabilization and recovery efforts, and the success of vaccine distribution programs.
Liquidity and Capital Resources
We have financed our operations since inception primarily through private placements and public offerings of our common stock. As of March 31, 2022, we had cash and cash equivalents of approximately $23.7 million.
Net cash provided by operating activities was $3.0 million for the three months ended March 31, 2022 and net cash used in operating activities was $6.2 million for the three months ended March 31, 2021, respectively. The increase in cash provided from operating activities for the period ended March 31, 2022 when compared to same period in 2021 was primarily due to a $10.0 million payment received pursuant to our license and product supply agreement with Heska Corporation, partly offset by higher payroll costs, and higher amounts paid to suppliers during the period.
Net cash used in investing activities was $0.1 million and $0.5 million for the three months ended March 31, 2022 and March 31, 2021, respectively. The decrease was primarily due to a decrease in purchases of laboratory equipment.
Net cash provided by financing activities was $0.4 million for the three months ended March 31, 2022 and net cash provided by financing activities was $20.2 million for the comparable period ended March 31, 2021. The decrease in cash provided by financing activities for the period ended March 31, 2022 when compared to same period in 2021 was primarily due to $18.9 million in net cash received from the issuance of shares of common stock in a registered public offering in February 2021 and $1.5 million in net cash received from the issuance of shares of common stock under our ATM facility during the period ended March 31, 2021.
| 28 |
| Table Of Contents |
The following table summarizes our approximate contractual payments due by year as of March 31, 2022.
Approximate Payments (Including Interest) Due by Year | ||||||||||||||||
|
|
|
|
|
|
|
|
|
||||||||
|
|
Total |
|
|
2022 (Remaining) |
|
|
2023 - 2026 |
|
|
2027 + |
|
||||
Description |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Finance Lease Obligations |
|
|
604,242 |
|
|
|
44,760 |
|
|
|
238,718 |
|
|
|
320,764 |
|
Operating Lease Obligations |
|
|
904,061 |
|
|
|
229,100 |
|
|
|
674,961 |
|
|
|
- |
|
Grants Repayable |
|
|
289,006 |
|
|
|
43,195 |
|
|
|
105,486 |
|
|
|
140,325 |
|
Long-Term Debt |
|
|
3,694,920 |
|
|
|
1,250,098 |
|
|
|
1,846,436 |
|
|
|
598,386 |
|
Collaborative Agreements Obligations |
|
|
767,678 |
|
|
|
767,678 |
|
|
|
- |
|
|
|
- |
|
Total |
|
|
6,259,907 |
|
|
|
2,334,831 |
|
|
|
2,865,601 |
|
|
|
1,059,475 |
|
We intend to use our cash reserves to fund further research and development activities and launch new products. We do not currently have sufficient revenues to cover our annual expenses and expect to rely on financing our operations in future periods, mainly through the sale of equity or debt securities, and licensing rights, to provide sufficient funding to execute our strategic plan. However, there can be no assurance that we will be successful in raising additional funds, or that we will be able to do so on terms that are satisfactory to us.
In the event that additional financing is delayed, we will prioritize the maintenance of our research and development personnel and facilities, primarily in Belgium, and the maintenance of our patent rights. In such instance, the completion of clinical validation studies and regulatory approval processes for the purpose of bringing products to the in vitro diagnostics markets would be delayed. In the event of an ongoing lack of financing, it may be necessary to discontinue operations, which will adversely affect the value of our common stock.
We have not attained profitable operations on an ongoing basis and are dependent upon obtaining financing to pursue any extensive activities. For these reasons, our auditors stated in their report on our audited financial statements for the fiscal year ended December 31, 2021 an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern.
| 29 |
| Table Of Contents |
Results of Operations
Comparison of the Three-Months Ended March 31, 2022 and March 31, 2021.
The following table sets forth our results of operations for the three months ended on March 31, 2022 and March 31, 2021, respectively.
|
|
Three Months Ended March 31, |
|
|
Increase |
|
|
Increase |
|
|||||||
|
|
2022 |
|
|
2021 |
|
|
(Decrease) |
|
|
(Decrease) |
|
||||
|
|
$ |
|
|
$ |
|
|
$ |
|
|
% |
|
||||
Services |
|
|
60,254 |
|
|
|
- |
|
|
|
60,254 |
|
|
>100 | % | |
Product |
|
|
53,957 |
|
|
|
25,530 |
|
|
|
28,427 |
|
|
>100 | % | |
Total Revenues |
|
|
114,211 |
|
|
|
25,530 |
|
|
|
88,681 |
|
|
>100 | % | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,590,053 |
|
|
|
3,873,079 |
|
|
|
(283,026 | ) |
|
(7 |
%) | |
General and administrative |
|
|
2,602,152 |
|
|
|
1,810,160 |
|
|
|
791,992 |
|
|
|
44 | % |
Sales and marketing |
|
|
1,598,983 |
|
|
|
427,401 |
|
|
|
1,171,582 |
|
|
>100 | % | |
Total Operating Expenses |
|
|
7,791,188 |
|
|
|
6,110,640 |
|
|
|
1,680,548 |
|
|
|
28 | % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
2 |
|
|
|
1,721 |
|
|
|
(1,719 | ) |
|
(100 |
%) | |
Interest expense |
|
|
(41,032 | ) |
|
|
(42,181 | ) |
|
|
1,149 |
|
|
(3 |
%) |
|
Total Other Income / (Expenses) |
|
|
(41,030 | ) |
|
|
(40,460 | ) |
|
|
(570 | ) |
|
|
1 | % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
(7,718,007 | ) |
|
|
(6,125,570 | ) |
|
|
1,592,437 |
|
|
|
26 | % |
Revenues
Our operations are transitioning from a research and development focused stage to a commercialization stage. Revenues during the three-months ended March 31, 2022 were $114,211, compared with $25,530 for the three-months ended March 31, 2021. The main source of revenue during the three months ended March 31, 2022 was services revenues from our Nu.Q® Discover offering and product revenues from sales of the Nu.Q® Vet Cancer Screening Test and H3.1 kits. The primary source of revenue during the three-months ended March 31, 2021 was direct sales of the Nu.Q® Vet Cancer Screening Test via the Gastrointestinal Laboratory at Texas A&M University.
Operating Expenses
Total operating expenses increased to $7.8 million for the three months ended March 31, 2022 from $6.1 million for the three months ended March 31, 2021, as a result of the factors described below.
| 30 |
| Table Of Contents |
Research and Development Expenses
Research and development expenses declined to $3.6 million from $3.9 million and for the three-months ended March 31, 2022 and March 31, 2021, respectively. This decline was primarily related to lower direct and other research and development expenses, partly offset by higher personnel expenses and stock-based compensation. The number of full-time equivalent (“FTE”) personnel we employed in this division increased by 10 to 55 compared to the prior year period.
|
|
Three Months Ended March 31, |
|
|
|
|||||||
|
|
2022 |
|
|
2021 |
|
|
Change |
|
|||
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
Personnel expenses |
|
|
1,775,719 |
|
|
|
1,492,444 |
|
|
|
283,275 |
|
Stock-based compensation |
|
|
191,167 |
|
|
|
90,127 |
|
|
|
101,040 |
|
Direct research and development expenses |
|
|
1,331,283 |
|
|
|
1,642,619 |
|
|
|
(311,336 | ) |
Other research and development |
|
|
145,333 |
|
|
|
402,017 |
|
|
|
(256,684 | ) |
Depreciation and amortization |
|
|
146,551 |
|
|
|
245,872 |
|
|
|
(99,321 | ) |
Total research and development expenses |
|
|
3,590,053 |
|
|
|
3,873,079 |
|
|
|
(283,026 | ) |
General and Administrative Expenses
General and administrative expenses increased to $2.6 million from $1.8 million for the three-months ended March 31, 2022 and March 31, 2021, respectively. This increase was primarily due to higher personnel expenses and stock-based compensation during the period. The FTE personnel number within this division increased by 5 to 19 compared to the prior year period.
|
|
Three Months Ended March 31, |
|
|
|
|||||||
|
|
2022 |
|
|
2021 |
|
|
Change |
|
|||
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
Personnel expenses |
|
|
1,173,180 |
|
|
|
617,071 |
|
|
|
556,109 |
|
Stock-based compensation |
|
|
444,801 |
|
|
|
333,866 |
|
|
|
110,935 |
|
Legal and professional fees |
|
|
505,853 |
|
|
|
560,778 |
|
|
|
(54,925 | ) |
Other general and administrative |
|
|
347,384 |
|
|
|
266,927 |
|
|
|
80,457 |
|
Depreciation and amortization |
|
|
130,934 |
|
|
|
31,518 |
|
|
|
99,416 |
|
Total general and administrative expenses |
|
|
2,602,152 |
|
|
|
1,810,160 |
|
|
|
791,992 |
|
Sales and Marketing Expenses
Sales and marketing expenses increased to $1.6 million from $0.4 million for the three-months ended March 31, 2022 and March 31, 2021, respectively. This increase was primarily due to higher personnel expenses, stock-based compensation and direct marketing and professional fees during the period. The FTE personnel number within this division increased by 11 to 18 compared to the prior year period.
|
|
Three Months Ended March 31, |
|
|
|
|||||||
|
|
2022 |
|
|
2021 |
|
|
Change |
|
|||
|
|
$ |
|
|
$ |
|
|
$ |
|
|||
Personnel expenses |
|
|
1,017,091 |
|
|
|
184,137 |
|
|
|
832,954 |
|
Stock-based compensation |
|
|
279,063 |
|
|
|
131,349 |
|
|
|
147,714 |
|
Direct marketing and professional fees |
|
|
290,643 |
|
|
|
111,915 |
|
|
|
178,728 |
|
Depreciation and amortization |
|
|
12,186 |
|
|
|
- |
|
|
|
12,186 |
|
Total sales and marketing expenses |
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1,598,983 |
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427,401 |
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1,171,582 |
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Other Income (Expenses)
For the three-months ended March 31, 2022, the Company’s other expenses were $41,030 compared to other expenses of $40,460 for the three-months ended March 31, 2021. This increase in other expenses was primarily related to the decrease in interest earned during the period.
Net Loss
For the three-months ended March 31, 2022, the Company’s net loss was $7.7 million, an increase of approximately $1.6 million in comparison to a net loss of $6.1 million for the three-months ended March 31, 2021. The change was a result of the factors described above.
Going Concern
We have not attained profitable operations on an ongoing basis and are dependent upon obtaining external financing to continue to pursue our operational and strategic plans. For these reasons, management has determined that there is substantial doubt that the business will be able to continue as a going concern without further financing.
Off-Balance Sheet Arrangements
We have no significant off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to stockholders.
Future Financings
We may seek to obtain additional capital through the sale of debt or equity securities if we deem it desirable or necessary. These sales may include the sale of equity securities from time to time through an “at the market offering program” under an Equity Distribution Agreement. However, we may be unable to obtain such additional capital when needed, or on terms favorable to us or our stockholders, if at all. If we raise additional funds by issuing equity securities, the percentage ownership of our stockholders will be reduced, stockholders may experience additional dilution, or such equity securities may provide for rights, preferences or privileges senior to those of the holders of our common stock. If additional funds are raised through the issuance of debt securities, the terms of such securities may place restrictions on our ability to operate our business.
Critical Accounting Policies and Estimates
Our interim condensed consolidated financial statements and accompanying notes have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, applied on a consistent basis. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods.
We regularly evaluate the accounting policies and estimates that we use to prepare our financial statements. A summary of these policies is included in the notes to our financial statements. In general, management’s estimates are based on current facts, historical experiences, information from third party professionals and various other factors that it believes to be reasonable under the circumstances. Actual results could differ materially and adversely from those estimates made by management. To the extent there are material differences between the estimates and the actual results, future results of operations could be affected.
Recently Issued Accounting Pronouncements
The Company has implemented all applicable new accounting pronouncements that are in effect. The Company does not believe that there are any other applicable new accounting pronouncements that have been issued that might have a material impact on its financial position or results of operations.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company and are not required to disclose this information.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Disclosure controls and procedures are controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by our company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our Principal Executive and Principal Financial Officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Our management carried out an evaluation, under the supervision and with the participation of our Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer have concluded, as they previously concluded as of December 31, 2021, that our disclosure controls and procedures were not effective as of March 31, 2022, because of material weaknesses in our internal control over financial reporting, as referenced below and described in detail in our Annual Report.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
In our Annual Report, the deficiencies identified involved the segregation of duties in some areas of finance.
We have already taken steps towards remediating such deficiencies including:
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hired an additional full-time Business Controller in Belgium with an appropriate level of experience; |
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hired an experienced financial planning and analysis manager to implement forecasting and budgeting processes; |
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changed organizational reporting lines and reallocated certain responsibilities to improve segregation of duties; and |
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implemented additional review procedures at each month end close. |
We intend to take additional measures around certain processes we have identified which we believe once implemented in conjunction with the completed actions above will mitigate and remedy this weakness.
We also intend to take additional steps to further strengthen the control environment. Such measures include but may not be limited to:
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recruitment of a specialist in Human Resources to recommend and implement relevant policies and processes that will strengthen the control environment; |
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further strengthening our internal processes and reviews, including formal documentation thereof; |
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preparation of risk-control matrices to identify key risks and develop and document policies to mitigate those risks; and |
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engaging additional resources if necessary to help us assess, document, design and implement control activities related to internal control over financial reporting. |
As we continue to evaluate and test the remediation plan outlined above, we may also identify additional measures to address the material weaknesses or modify certain of the remediation procedures described above. We also may implement additional changes to our internal control over financial reporting as may be appropriate in the course of remediating the material weakness. Management, with the oversight of our audit committee, will continue to take steps necessary to remedy the material weakness to reinforce the overall design and capability of our control environment.
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Changes in Internal Control over Financial Reporting
Except for the ongoing remediation of the material weaknesses in internal controls over financial reporting noted above, no changes in our internal control over financial reporting were made during the fiscal quarter ended March 31, 2022, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations of the Effectiveness of Disclosure Controls and Internal Controls
Our management, including our Principal Executive Officer and Principal Financial Officer, does not expect that our disclosure controls and internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.
The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving our stated goals under all potential future conditions; over time, a control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
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PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
In the ordinary course of business, we may be subject to claims, counter claims, lawsuits and other litigation of the type that generally arise from the conduct of our business. We know of no material, existing or pending legal proceedings against our company, nor are we involved as a plaintiff in any material proceeding or pending litigation. There are no proceedings in which our directors, officers or any affiliates, or any registered or beneficial stockholders, is an adverse party or has a material interest adverse to our interest.
ITEM 1A. RISK FACTORS
There have been no material changes in our assessment of risk factors affecting our business since those presented in Part I, Item 1A of our Annual Report.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Recent Sales of Unregistered Securities
None.
Repurchase of Equity Securities
No equity securities were repurchased during the first quarter of 2022.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Termination of Equity Distribution Agreement
Effective May 7, 2022, the Company terminated its Equity Distribution Agreement dated September 24, 2021 with Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. (the “2021 EDA”) and no further sales of the Company’s common stock will be made under the 2021 EDA. From inception through May 7, 2022, the Company raised aggregate net proceeds (net of brokers’ commissions and fees) of approximately $0.7 million under the 2021 EDA through the sale of 193,600 shares of its common stock.
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ITEM 6. EXHIBITS
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Incorporated by Reference |
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Exhibit Number |
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Exhibit Description |
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Form |
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File No. |
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Exhibit |
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Filing Date |
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Filed Herewith |
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License and Supply Agreement between Belgian Volition and Heska Corporation, dated March 28, 2022. |
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101.INS |
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XBRL Instance Document. |
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101.SCH |
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XBRL Taxonomy Extension Schema Document. |
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101.CAL |
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XBRL Taxonomy Extension Calculation Linkbase Document. |
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101.LAB |
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XBRL Taxonomy Extension Label Linkbase Document. |
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101.PRE |
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XBRL Taxonomy Extension Presentation Linkbase Document. |
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101.DEF |
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XBRL Taxonomy Extension Definition Linkbase Document. |
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104 |
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Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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† |
Portions of this exhibit are redacted pursuant to Item 601(a)(6) and/or Item (b)(10)(iv) under Regulation S-K. The registrant agrees to furnish supplementally any omitted schedules to the SEC upon request. |
* |
The certifications attached as Exhibit 32.1 accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the registrant for purposes of Section 18 of the Exchange Act and are not to be incorporated by reference into any of the registrant’s filings under the Securities Act or the Exchange Act, irrespective of any general incorporation language contained in any such filing. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
VOLITIONRX LIMITED |
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Dated: May 11, 2022 |
By: | /s/ Cameron Reynolds |
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Cameron Reynolds | |
| President and Chief Executive Officer | |||
| (Authorized Signatory and Principal Executive Officer) | |||
Dated: May 11, 2022 |
By: | /s/ Terig Hughes | |
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Terig Hughes | |
| Chief Financial Officer and Treasurer | |||
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(Authorized Signatory and Principal Financial and Accounting Officer) |
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