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) |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |
(Address of principal executive offices) | (Zip Code) |
+1 (
(Registrant’s telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
☒ | Smaller reporting company | ||
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
As of November 6, 2024, there were
VOLITIONRX LIMITED
QUARTERLY REPORT ON FORM 10-Q
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024
TABLE OF CONTENTS
PAGE |
| ||||
|
|
|
|
| |
4 |
| ||||
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 31 |
| |||
39 |
| ||||
39 |
| ||||
|
|
|
|
| |
| |||||
|
|
|
|
| |
41 |
| ||||
41 |
| ||||
41 |
| ||||
41 |
| ||||
41 |
| ||||
41 |
| ||||
42 |
| ||||
|
|
|
|
| |
44 |
| ||||
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., 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, Capture-PCRTM, 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 September 30, 2024, 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, which statements are subject to considerable risks and uncertainties. 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, statements regarding predictions of earnings, revenues, expenses or other financial items; plans or expectations with respect to our development activities or business strategy; clinical studies and results; industry trends; anticipated demand for our products, or the products of our competitors; manufacturing forecasts, and the potential impact of our relationship with contract manufacturers and original equipment manufacturers on our business; the commercialization of our products and the relationships and anticipated outcome of our engagements with our licensors; the future cost and potential benefits of our research and development efforts; forecasts of our liquidity position or available cash resources; our anticipated use of our cash reserves; the impact of pending litigation; and statements relating to the assumptions underlying any of the foregoing. Throughout this Report, we have attempted to identify forward-looking statements by using words such as “may,” “believe,” “will,” “could,” “project,” “anticipate,” “expect,” “estimate,” “should,” “continue,” “potential,” “plan,” “forecasts,” “goal,” “seek,” “intend,” other forms of these words or similar words or expressions or the negative thereof (although not all forward-looking statements contain these words).
We have based our forward-looking statements on our current expectations and projections about trends affecting our business and industry and other future events. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. Forward-looking statements are subject to substantial risks and uncertainties that could cause our future business, financial condition, results of operations or performance, to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this Report.
Some significant factors that may impact our estimates and forward-looking statements include, but are not limited to:
· | Our inability to generate any significant revenues or achieve profitability; |
· | Our need to raise additional capital in the future; |
· | Our expansion of our product development and sales and marketing capabilities could give rise to difficulties in managing our growth; |
· | Our dependence on third-party distributors; |
· | Our limited experience with sales and marketing; |
· | The possibility that we may not be able to continue to operate, as indicated by the “going concern” opinion from our auditors; |
· | Our ability to successfully develop, manufacture, market, and sell our future products; |
· | Our ability to timely obtain necessary regulatory clearances or approvals to distribute and market our future products; |
· | The acceptance by the marketplace of our future products; |
· | The highly competitive and rapidly changing nature of the diagnostics market; |
· | Protection of our patents, intellectual property and trade secrets; |
· | Our reliance on third parties to manufacture and supply our intended products, and such manufacturers’ dependence on third-party suppliers; |
· | Pressures related to macroeconomic and geopolitical conditions; |
· | The material weaknesses in our internal control over financial reporting that we have identified; and |
· | Other risks identified elsewhere in this Report, as well as in our other filings with the Securities and Exchange Commission or (the “SEC”). |
In addition, actual results may differ as a result of additional risks and uncertainties of which we are currently unaware or which we do not currently view as material to our business. For these reasons, readers are cautioned not to place undue reliance on any forward-looking statements. Our actual financial condition and results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed in the sections entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” within this Report, as well as in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the SEC on March 25, 2024, or our Annual Report, in 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. Except as required by law or the listing rules of the NYSE American Market, we expressly disclaim any intent or obligation to update any forward-looking statements after the date hereof. If we do update or correct any forward-looking statements, readers should not conclude that we will make additional updates or corrections. We qualify all of our forward-looking statements with these cautionary statements.
| 3 |
| Table of Contents |
PART I FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)
| Page |
| |
|
| ||
| 5 |
| |
Condensed Consolidated Statements of Operations and Comprehensive Loss |
| 6 |
|
| 7 |
| |
| 9 |
| |
| 10 |
|
| 4 |
| Table of Contents |
VOLITIONRX LIMITED
Condensed Consolidated Balance Sheets
(Expressed in United States Dollars, except share numbers)
|
| September 30, |
|
| December 31, |
| ||
|
| 2024 |
|
| 2023 |
| ||
|
| $ |
|
| $ |
| ||
ASSETS |
| (UNAUDITED) |
|
|
|
| ||
Current Assets |
|
|
|
|
|
| ||
Cash and cash equivalents |
|
|
|
|
|
| ||
Accounts receivable |
|
|
|
|
|
| ||
Prepaid expenses |
|
|
|
|
|
| ||
Other current assets |
|
|
|
|
|
| ||
Total Current Assets |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
|
|
|
| ||
Operating lease right-of-use assets |
|
|
|
|
|
| ||
Intangible assets, net |
|
|
|
|
|
| ||
Total Assets |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
|
| ||
Accrued liabilities |
|
|
|
|
|
| ||
Deferred revenue |
|
|
|
|
|
| ||
Management and directors’ fees payable |
|
|
|
|
|
| ||
Current portion of long-term debt |
|
|
|
|
|
| ||
Current portion of finance lease liabilities |
|
|
|
|
|
| ||
Current portion of operating lease liabilities |
|
|
|
|
|
| ||
Current portion of grant repayable |
|
|
|
|
|
| ||
Warrant liability |
|
|
|
|
|
| ||
Total Current Liabilities |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Long-term debt, net of current portion |
|
|
|
|
|
| ||
Finance lease liabilities, net of current portion |
|
|
|
|
|
| ||
Operating lease liabilities, net of current portion |
|
|
|
|
|
| ||
Grant repayable, net of current portion |
|
|
|
|
|
| ||
Total Long-Term Liabilities |
|
|
|
|
|
| ||
Total Liabilities |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Stockholders' Deficit |
|
|
|
|
|
|
|
|
Common Stock |
|
|
|
|
|
|
|
|
Authorized: |
|
|
|
|
|
|
|
|
Issued and outstanding: |
|
|
|
|
|
| ||
Additional paid-in capital |
|
|
|
|
|
| ||
Accumulated other comprehensive income |
|
|
|
|
|
| ||
Accumulated deficit |
|
| ( | ) |
|
| ( | ) |
Total VolitionRx limited Stockholders' Deficit |
|
| ( | ) |
|
| ( | ) |
Non-controlling interest |
|
| ( | ) |
|
| ( | ) |
Total Stockholders’ Deficit |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
Total Liabilities and Stockholders’ Deficit |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
(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)
|
| Three Months Ended September 30, |
|
| Nine Months Ended September 30, |
| ||||||||||
|
| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| ||||
|
| $ |
|
| $ |
|
| $ |
|
| $ |
| ||||
Revenues |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Services |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Product |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Total Revenues |
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
|
|
|
|
|
|
|
|
| ||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Sales and marketing |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Total Operating Expenses |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Operating Loss |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income (Expenses) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Loss on disposal of fixed assets |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
Interest income |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Interest expense |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
Gain on change in fair value of warrant liability |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Total Other Income (Expenses) |
|
|
|
|
|
|
|
| ( | ) |
|
|
| |||
Net Loss |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
Net Loss Attributable to Non-Controlling Interest |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Net Loss Attributable to VolitionRx Limited Stockholders |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Comprehensive Income (Loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
|
| ( | ) |
|
|
|
|
| ( | ) |
|
|
| ||
Net Comprehensive Loss |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss Per Share – Basic and Diluted Attributable to VolitionRx Limited |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average Shares Outstanding– Basic and Diluted |
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(The accompanying notes are an integral part of these condensed consolidated financial statements) | ||||||||||||||||
| 6 |
| Table of Contents |
VOLITIONRX LIMITED
Condensed Consolidated Statements of Stockholders’ Deficit (Unaudited)
(Expressed in United States Dollars, except share numbers)
For the Nine Months Ended September 30, 2024 and September 30, 2023 | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
|
|
|
|
|
|
|
|
|
|
| Accumulated |
|
|
|
|
|
|
|
|
|
| |||||||
|
|
|
|
|
|
|
| Additional |
|
| Other |
|
|
|
|
| Non - |
|
|
|
| |||||||
|
| Common Stock |
|
| Paid-in |
|
| Comprehensive |
|
| Accumulated |
|
| Controlling |
|
|
|
| ||||||||||
|
| Shares |
|
| Amount |
|
| Capital |
|
| Income |
|
| Deficit |
|
| Interest |
|
| Total |
| |||||||
|
| # |
|
| $ |
|
| $ |
|
| $ |
|
| $ |
|
| $ |
|
| $ |
| |||||||
Balance, December 31, 2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for cash, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
Common stock issued for settlement of RSUs |
|
|
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Common stock issued in lieu of license fee |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
Stock-based compensation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Tax withholdings paid related to stock-based compensation |
|
| - |
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
| ( | ) | ||||
Foreign currency translation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Net loss for the period |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | |||
Balance, March 31, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for cash, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
Common stock issued for settlement of RSUs |
|
|
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Stock-based compensation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Tax withholdings paid related to stock-based compensation |
|
| - |
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
| ( | ) | ||||
Foreign currency translation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Net loss for the period |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | |||
Balance, June 30, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for cash, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
Common stock issued for settlement of RSUs |
|
|
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Stock-based compensation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Tax withholdings paid related to stock-based compensation |
|
| - |
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
| ( | ) | ||||
Foreign currency translation |
|
| - |
|
|
|
|
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
| ( | ) | |||
Net loss for the period |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | ||
Balance, September 30, 2024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | ||||
| ||||||||||||||||||||||||||||
(The accompanying notes are an integral part of these condensed consolidated financial statements) | ||||||||||||||||||||||||||||
| 7 |
| Table of Contents |
VOLITIONRX LIMITED
Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)
(Expressed in United States Dollars, except share numbers)
|
|
|
|
|
|
|
|
|
|
| Accumulated |
|
|
|
|
|
|
|
|
|
| |||||||
|
|
|
|
|
|
|
| Additional |
|
| Other |
|
|
|
|
| Non - |
|
|
|
| |||||||
|
| Common Stock |
|
| Paid-in |
|
| Comprehensive |
|
| Accumulated |
|
| Controlling |
|
|
|
| ||||||||||
|
| Shares |
|
| Amount |
|
| Capital |
|
| Income (Loss) |
|
| Deficit |
|
| Interest |
|
| Total |
| |||||||
|
| # |
|
| $ |
|
| $ |
|
| $ |
|
| $ |
|
| $ |
|
| $ |
| |||||||
Balance, December 31, 2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | ||||
Common stock issued for cash, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
Common stock issued for settlement of RSUs |
|
|
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Stock-based compensation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Tax withholdings paid related to stock-based compensation |
|
| - |
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
| ( | ) | ||||
Common stock repurchased |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
| ( | ) | |||
Foreign currency translation |
|
| - |
|
|
|
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
| ( | ) | ||||
Net loss for the period |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | |||
Balance, March 31, 2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | ||||
Common stock issued for cash, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||
Common stock issued for settlement of RSUs |
|
|
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Stock-based compensation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Tax withholdings paid related to stock-based compensation |
|
| - |
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
| ( | ) | ||||
Foreign currency translation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Net loss for the period |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | |||
Balance, June 30, 2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
|
| |||||
Issuance costs |
|
| - |
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
| ( | ) | ||||
Common stock issued for settlement of RSUs |
|
|
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Stock-based compensation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Tax withholdings paid related to stock-based compensation |
|
| - |
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
|
|
|
| ( | ) | ||||
Foreign currency translation |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Net loss for the period |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | |||
Balance, September 30, 2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) |
|
| ( | ) | ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(The accompanying notes are an integral part of these condensed consolidated financial statements) | ||||||||||||||||||||||||||||
| 8 |
| Table of Contents |
VOLITIONRX LIMITED
Condensed Consolidated Statements of Cash Flows (Unaudited)
(Expressed in United States Dollars)
|
| Nine Months Ended September 30, |
| |||||
|
| 2024 |
|
| 2023 |
| ||
|
| $ |
|
| $ |
| ||
Operating Activities |
|
|
|
|
|
| ||
Net loss |
|
| ( | ) |
|
| ( | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
|
|
|
| ||
Amortization of operating lease right-of-use assets |
|
|
|
|
|
| ||
Loss on disposal of fixed assets |
|
|
|
|
|
| ||
Stock-based compensation |
|
|
|
|
|
| ||
Gain on change in fair value of warrant liability |
|
| ( | ) |
|
| ( | ) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses |
|
| ( | ) |
|
| ( | ) |
Accounts receivable |
|
| ( | ) |
|
| ( | ) |
Other current assets |
|
| ( | ) |
|
| ( | ) |
Deferred revenue, current and non-current |
|
| ( | ) |
|
|
| |
Accounts payable and accrued liabilities |
|
| ( | ) |
|
|
| |
Management and directors’ fees payable |
|
| ( | ) |
|
| ( | ) |
Right-of-use assets operating leases liabilities |
|
| ( | ) |
|
| ( | ) |
Net Cash Used In Operating Activities |
|
| ( | ) |
|
| ( | ) |
Investing Activities |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
| ( | ) |
|
| ( | ) |
Purchase of License |
|
| ( | ) |
|
|
| |
Net Cash Used In Investing Activities |
|
| ( | ) |
|
| ( | ) |
Financing Activities |
|
|
|
|
|
|
|
|
Net proceeds from issuances of common stock |
|
|
|
|
|
| ||
Tax withholdings paid related to stock-based compensation |
|
| ( | ) |
|
| ( | ) |
Common stock repurchased |
|
|
|
|
| ( | ) | |
Proceeds from grants repayable |
|
|
|
|
|
| ||
Proceeds from long-term debt |
|
|
|
|
|
| ||
Payments on long-term debt |
|
| ( | ) |
|
| ( | ) |
Payments on grants repayable |
|
| ( | ) |
|
|
| |
Payments on finance lease obligations |
|
| ( | ) |
|
| ( | ) |
Net Cash Provided By Financing Activities |
|
|
|
|
|
| ||
Effect of foreign exchange on cash |
|
| ( | ) |
|
|
| |
Net change in cash and cash equivalents |
|
| ( | ) |
|
| ( | ) |
Cash and cash equivalents – beginning of the period |
|
|
|
|
|
| ||
Cash and cash equivalents – End of Period |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Supplemental Disclosures of Cash Flow Information |
|
|
|
|
|
|
|
|
Interest paid |
|
|
|
|
|
| ||
Non-Cash Financing Activities |
|
|
|
|
|
|
|
|
Common stock issued upon cashless exercises of stock options and settlement of vested RSUs |
|
|
|
|
|
| ||
Offering costs from issuance of common stock |
|
|
|
|
|
| ||
Fair value of warrants issued in connection with public offering |
|
|
|
|
|
| ||
Common stock issued for License rights |
|
|
|
|
|
| ||
Non-cash note payable |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
(The accompanying notes are an integral part of these condensed consolidated financial statements) | ||||||||
| 9 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 1 – Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation and use of estimates
The accompanying unaudited condensed consolidated financial statements of VolitionRx Limited (the “Company” or “VolitionRx”) have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q of Regulation S-X. They do not include all the information and footnotes required by GAAP for complete financial statements. The December 31, 2023 consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by GAAP. However, except as disclosed herein, there has been no material change in the information disclosed in the notes to the audited consolidated financial statements and accompanying notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, as filed with the Securities and Exchange Commission on March 25, 2024 (the “Annual Report”). The interim unaudited condensed consolidated financial statements should be read in conjunction with those audited consolidated financial statements included in the Annual Report. In the opinion of management, all adjustments considered necessary for a fair presentation of the financial statements, consisting solely of normal recurring adjustments, have been made. Operating results for the nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024.
The preparation of the Company's Condensed Consolidated Financial Statements requires management to make certain estimates and assumptions about future events. These estimates and the underlying assumptions affect the amounts of assets and liabilities reported and reported amounts of revenues and expenses. Such estimates include impairment of long-lived assets, accounts receivable, useful lives of intangible assets and property and equipment, fair values of stock-based awards, income taxes among others. These estimates and assumptions are based on management’s judgment. Estimates and underlying assumptions are reviewed on an ongoing basis. Changes in accounting estimates may be necessary if there are changes in the circumstances or experiences on which the estimate was based or as a result of new information. Changes in estimates, including those resulting from changes in the economic environment, are reflected in the period in which the change in estimate occurs.
Reclassifications
Certain reclassifications within operating expenses have been made to the prior period’s financial statements to conform to the current period financial statement presentation. There is no impact in total to the results of operations and cash flows in all periods presented.
Recently Issued Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (the “FASB” issued Accounting Standards Update (“ASU”) 2023-07, “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures,” which requires a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about reportable segment’s profit or loss and assets that are currently required annually. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. These amendments are to be applied retrospectively. The Company is currently evaluating the impact this standard will have on its annual and interim consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures,” which enhances the transparency and decision usefulness of income tax disclosures by requiring: (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. These amendments are to be applied prospectively, with retrospective application permitted. The Company is currently evaluating the impact this standard will have on its annual and interim consolidated financial statements.
The Company currently believes there are no other issued and not yet effective accounting standards that are materially relevant to its condensed consolidated financial statements.
| 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)
Fair Value Measurements
Pursuant to ASC 820, “Fair Value Measurements and Disclosures,” an entity is required to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 establishes a fair value hierarchy based on the level of independent, objective evidence surrounding the inputs used to measure fair value. A financial instrument’s categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. ASC 820 prioritizes the inputs into three levels that may be used to measure fair value:
Level 1
Level 1 applies to assets or liabilities for which there are quoted prices in active markets for identical assets or liabilities.
Level 2
Level 2 applies to assets or liabilities for which there are inputs other than quoted prices that are observable for the assets or liabilities such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical assets or liabilities in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data.
Level 3
Level 3 applies to assets or liabilities for which there are unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of the assets or liabilities.
The financial instruments of the Company consist primarily of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, debt, and a warrant liability. These items are considered Level 1 due to their short-term nature and their market interest rates, except for the warrant liability, which is considered Level 2 and is recorded at fair value at the end of each reporting period.
Included in the following table are the Company’s major categories of assets and liabilities measured at fair value on a recurring basis as of September 30, 2024.
Fair Value Measurements at September 30, 2024 | ||||||||||||||||
Description | Level 1 | Level 2 | Level 3 | Total | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Liabilities | ||||||||||||||||
Warrant liability | ||||||||||||||||
As of December 31, 2023, the warrant liability was $
Warrant Liability | ||||
Total | ||||
$ | ||||
Balance at December 31, 2023 | ||||
Gain on change in fair value of warrant liability | ( | ) | ||
Balance at September 30, 2024 | ||||
Basic and Diluted Net Loss Per Share
The Company computes net loss per share in accordance with ASC 260, “Earnings Per Share,” which requires presentation of both basic and diluted earnings per share (“EPS”) on the face of the statement of operations and comprehensive loss. Basic EPS is computed by dividing net loss available to common stockholders (numerator) by the weighted average number of shares outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period using the treasury stock method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. As of September 30, 2024,
| 11 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 2 – Liquidity and Going Concern Assessment
The Company's condensed consolidated financial statements are prepared using GAAP applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. Management assesses liquidity and going concern uncertainty in the Company’s consolidated financial statements to determine whether there is sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued, which is referred to as the “look-forward period,” as defined in GAAP. As part of this assessment, based on conditions that are known and reasonably knowable to management, management considered various scenarios, forecasts, projections, estimates and made certain key assumptions, including the timing and nature of projected cash expenditures or programs, its ability to delay or curtail expenditures or programs and its ability to raise additional capital, if necessary, among other factors.
For the nine months ended September 30, 2024, the Company incurred a net loss of $
The Company has generated operating losses and has experienced negative cash flows from operations since inception. The Company has not generated significant revenues and expects to incur further losses in the future, particularly from continued development of its clinical-stage diagnostic tests and commercialization activities. The future of the Company as an operating business will depend on its ability to obtain sufficient capital contributions or, financing, and/or generate revenues as may be required to sustain its operations. Management plans to address the above as needed by, (a) granting licenses and/or distribution rights to third parties in exchange for specified up-front and/or back-end payments, (b) obtaining additional financing through debt or equity transactions, (c) securing additional grant funds, and (d) developing and commercializing its products in an efficient manner. Management continues to exercise tight cost controls to conserve cash. As part of the Company’s cash conservation efforts, directors and certain employees have elected to exchange a portion of their fees earned or paid in cash or salary, respectively, for RSUs in the Company for a period of up to six months.
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 to eventually attain profitable operations.
Management assessed the mitigating effect of these plans to determine if it is probable that the plans would be effectively implemented within one year after the condensed consolidated financial statements are issued and when implemented, would mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern. These plans are subject to market conditions and reliance on third parties, and there is no assurance that effective implementation of the Company’s plans will result in the necessary funding to continue current operations and satisfy current and expected debt obligations. The Company has implemented short-term cash preservation and cost-saving initiatives to conserve cash. The Company concluded that these plans do not alleviate the substantial doubt about the Company’s ability to continue as a going concern beyond one year from the date the condensed consolidated financial statements are issued.
The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The accompanying consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and their carrying amounts, or the amounts and classification of liabilities that may result should the Company be unable to continue as a going concern. If the Company is unable to obtain adequate capital, it could be forced to cease operations.
| 12 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 3 - Property and Equipment
The Company’s property and equipment consisted of the following amounts as of September 30, 2024 and December 31, 2023:
September 30, 2024 | December 31, 2023 | |||||||||
Useful Life | Cost $ | Cost $ | ||||||||
Computer hardware and software | ||||||||||
Laboratory equipment | ||||||||||
Office furniture and equipment | ||||||||||
Buildings | ||||||||||
Building improvements | ||||||||||
Land | Not amortized | |||||||||
Total property and equipment | ||||||||||
Less accumulated depreciation | ||||||||||
Total property and equipment, net | ||||||||||
During the nine-month periods ended September 30, 2024 and September 30, 2023, the Company recognized $
| 13 |
| 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.
September 30, 2024 | December 31, 2023 | |||||||
Cost $ | Cost $ | |||||||
Patents | ||||||||
Licenses | ||||||||
Total Patents and Licenses | ||||||||
Less accumulated amortization | ||||||||
Total patents and Licenses, net | ||||||||
During the nine-month periods ended September 30, 2024 and September 30, 2023, the Company recognized $(
The Company amortizes the patents and licenses on a straight-line basis with terms ranging from
2024 | $ | |||
2025 | $ | |||
2026 | $ | |||
2027 | $ | |||
2028 | $ | |||
Greater than 5 years | $ | |||
Total Intangible Assets | $ |
The Company periodically reviews its long-lived assets to ensure that their carrying value does not exceed their fair market value. The Company carried out such a review in accordance with ASC 360, “Property, Plant and Equipment,” as of December 31, 2023. The result of this review confirmed that the ongoing value of the patents was not impaired as of December 31, 2023.
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 consultancy services which are accrued under management and directors’ fees payable (see condensed consolidated balance sheets).
| 14 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 6 - Common Stock
As of September 30, 2024, the Company was authorized to issue
Stock Option Exercises
During the nine months ended September 30, 2024, no shares of common stock were issued pursuant to the exercise of stock options.
Stock Options Expired / Cancelled
On April 16, 2024,
RSU Settlements
Below is a table summarizing the RSUs that vested and settled during the nine months ended September 30, 2024, all of which were issued pursuant to the 2015 Plan.
Equity Incentive Plan | RSUs Vested (#) | Vest Date | Shares Issued (#) | Shares Withheld for Taxes (#) | ||||||||||
| 15 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 6 - Common Stock (continued)
2023 Equity Capital Raise
In connection with the June 2023 underwritten public offering of the Company’s common stock under the Company’s Registration Statement on Form S-3 (File No. 333-259783) effective November 8, 2021 (the “2021 Form S-3”), and pursuant to the underwriting agreement with Prime Executions, Inc, doing business as Freedom Capital Markets (“Freedom”), dated June 1, 2023, (the “2023” Equity Capital Raise”) the Company issued as compensation to Freedom warrants to purchase an aggregate of
The fair value of the warrants issued in the 2023 Equity Capital Raise as of September 30, 2024, and December 31, 2023, were $
September 30, 2024 | December 31, 2023 | |||||||
Risk-free interest rate | % | % | ||||||
Expected volatility | % | % | ||||||
Expected life (years) | ||||||||
Expected dividend yield | ||||||||
Total fair value | $ | $ | ||||||
The fair value of the warrants issued in the 2023 Equity Capital Raise was deemed to be a liability, due to certain contingent put features, and was determined using the Black-Scholes option pricing model, which was deemed to be an appropriate model due to the terms of the warrants issued, including a fixed term and exercise price.
| 16 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 6 - Common Stock (continued)
2024 Equity Capital Raise
On August 8, 2024, the Company entered into a securities purchase agreement with a purchaser pursuant to which the Company issued and sold to such purchaser, in a registered direct offering under the 2021 Form S-3 (the “2024 Equity Capital Raise”), an aggregate of
Common Stock Issued for EpiCypher License Agreement
On March 12, 2024, the Company issued
Equity Distribution Agreement
On May 20, 2022, the Company entered into an equity distribution agreement (the “2022 EDA”) with Jefferies LLC (“Jefferies”) to sell shares of the Company’s common stock, with an aggregate offering price of up to $
During the nine months ended September 30, 2024, the Company raised aggregate net proceeds (net of broker commissions and fees) of approximately $
| 17 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-Based Compensation
a) (i) Common Stock Warrants
The following table summarizes the changes in common stock warrants of the Company outstanding during the nine-month period ended September 30, 2024.
Number of Warrants | Weighted Average Exercise Price ($) | |||||||
Outstanding at December 31, 2023 | ||||||||
Granted | ||||||||
Expired/Cancelled | - | |||||||
Outstanding at September 30, 2024 | ||||||||
Exercisable at September 30, 2024 | ||||||||
Below is a table summarizing the common stock warrants issued and outstanding as of September 30, 2024, which have an aggregate weighted average remaining contractual life of
Number Outstanding | Number Exercisable | Exercise Price ($) | Weighted Average Remaining Contractual Life (Years) | Proceeds to Company if Exercised ($) | ||||||||||||||
| - | ||||||||||||||||||
Stock-based compensation expense related to warrants of $
| 18 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-Based Compensation (continued)
a) (ii) Warrants – Series A and Series B Common Stock Warrants
The following table summarizes the changes in Series A and Series B common stock warrants of the Company outstanding during the nine-month period ended September 30, 2024.
Number of Warrants | Weighted Average Exercise Price ($) | |||||||
Outstanding at December 31, 2023 | - | |||||||
Granted | ||||||||
Exercised | - | - | ||||||
Expired/Cancelled | - | |||||||
Outstanding at September 30, 2024 | ||||||||
Exercisable at September 30, 2024 | - | |||||||
Below is a table summarizing the Series A and Series B common stock warrants issued and outstanding as of September 30, 2024, which have a maximum aggregate weighted average remaining contractual life of
Description | Number Outstanding | Number Exercisable | Exercise Price ($) | Weighted Average Remaining Contractual Life (Years) | Proceeds to Company if Exercised ($) | |||||||||||||||
Investor A Warrants | - | |||||||||||||||||||
Investor B Warrants | - | |||||||||||||||||||
Placement Agent Series B Warrants | - | |||||||||||||||||||
| - | ||||||||||||||||||||
b) Options
The following table summarizes the changes in options outstanding of the Company during the nine-month period ended September 30, 2024.
|
| Number of Options |
|
| Weighted Average Exercise Price ($) |
| ||
Outstanding at December 31, 2023 |
|
|
|
|
|
| ||
Expired/Cancelled |
|
| ( | ) |
|
|
| |
Outstanding at September 30, 2024 |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Exercisable at September 30, 2024 |
|
|
|
|
|
| ||
| 19 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-Based Compensation (continued)
b) Options (continued)
Below is a table summarizing the options issued and outstanding as of September 30, 2024, all of which were issued pursuant to the Company’s 2011 Equity Incentive Plan (for option issuances prior to 2016) or the 2015 Plan (for option and RSU issuances commencing in 2016)and which have an aggregate weighted average remaining contractual life of
Number Outstanding |
|
| Number Exercisable |
|
| Exercise Price ($) |
|
| Weighted Average Remaining Contractual Life (Years) |
|
| Proceeds to Company if Exercised ($) |
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||
Stock-based compensation expense related to stock options of $nil and $
c) Restricted Stock Units
Below is a table summarizing the RSUs issued and outstanding as of September 30, 2024, all of which were issued pursuant to the 2015 Plan.
|
| RSUs (#) |
|
| Weighted Average Grant Date Fair Value Share Price ($) |
| ||
Outstanding at December 31, 2023 |
|
|
|
|
|
| ||
Granted |
|
|
|
|
|
| ||
Vested/Settled |
|
| ( | ) |
|
|
| |
Cancelled / Forfeited |
|
| ( | ) |
|
|
| |
Outstanding at September 30, 2024 |
|
|
|
|
|
| ||
| 20 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-Based Compensation (continued)
c) Restricted Stock Units (continued)
Below is a table summarizing the RSUs granted during the nine months ended September 30, 2024, all of which were issued pursuant to the 2015 Plan. The RSUs vest equally over periods stated on the dates noted, subject to the recipient’s continued service to the Company, and will result in the RSU compensation expense stated. On June 1, 2024, the Company granted
Equity Incentive Plan | RSUs Granted (#) | Grant Date | Vesting Period | First Vesting Date | Second Vesting Date | Third Vesting Date | RSU Expense ($) | |||||||
N/A | N/A | |||||||||||||
N/A | N/A | |||||||||||||
N/A | N/A | |||||||||||||
N/A | N/A | |||||||||||||
| 21 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 7 – Stock-Based Compensation (continued)
c) Restricted Stock Units (continued)
Below is a table summarizing the RSUs vested and settled during the nine months ended September 30, 2024, all of which were issued pursuant to the 2015 Plan.
Equity Incentive Plan |
| RSUs Vested (#) |
|
| Vest Date |
| Shares Issued (#) |
|
| Shares Withheld for Taxes (#) |
| |||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
|
| |||
| 22 |
| 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 (continued)
Below is a table summarizing the RSUs cancelled during the nine months ended September 30, 2024, all of which were originally issued pursuant to the 2015 Plan.
Equity Incentive Plan |
| RSUs (#) |
|
| Cancellation Date |
| Vesting Date |
| RSUs Cancelled (#) |
| ||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
| ||
| 23 |
| 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 (continued)
Below is a table summarizing the RSUs issued and outstanding as of September 30, 2024 and which have an aggregate weighted average remaining contractual life of
RSUs Outstanding (#) |
|
| Weighted Average Grant Date Fair Value Share Price ($) |
|
| Weighted Average Remaining Contractual Life (Years) |
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
| |||
|
|
|
|
|
|
|
|
|
| |
Stock-based compensation expense related to RSUs of $
| 24 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies
a) Finance Lease Obligations
The following is a schedule showing the future minimum lease payments under finance leases by years and the present value of the minimum payments as of September 30, 2024.
2024 - Remaining |
| $ |
| |
2025 |
| $ |
| |
2026 |
| $ |
| |
2027 |
| $ |
| |
2028 |
| $ |
| |
Greater than 5 years |
| $ |
| |
Total |
| $ |
| |
Less: Amount representing interest |
| $ | ( | ) |
Present value of minimum lease payments |
| $ |
|
b) Operating Lease Right-of-Use Obligations
Operating leases as of September 30, 2024, and December 31, 2023, consisted of the following:
|
| September 30, 2024 |
|
| December 31, 2023 |
| ||
|
| $ |
|
| $ |
| ||
Operating right-of-use assets |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Operating lease liabilities, current portion |
|
|
|
|
|
| ||
Operating lease liabilities, long term |
|
|
|
|
|
| ||
Total operating lease liabilities |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Weighted average remaining lease (months) |
|
|
|
|
|
| ||
Weighted average discount rate |
|
| % |
|
| % | ||
During the nine months ended September 30, 2024, cash paid for amounts included for the measurement of lease liabilities was $
| 25 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
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 September 30, 2024.
For the Nine Months Ending September 30, 2024 |
| Amount |
| |
|
| $ |
| |
2024 - Remaining |
|
|
| |
2025 |
|
|
| |
2026 |
|
|
| |
2027 |
|
|
| |
2028 |
|
|
| |
Total |
|
|
| |
Less: imputed interest |
|
| ( | ) |
Total Operating Lease Liabilities |
|
|
| |
The Company’s office space leases are short-term and the Company has elected under the short-term recognition exemption not to recognize them on the balance sheet. During the nine months ended September 30, 2024, the Company recognized $
For the Nine Months Ending September 30, 2024 |
| Amount |
| |
|
| $ |
| |
2024 - Remaining |
|
|
| |
2025 |
|
|
| |
Total Operating Lease Liabilities |
|
|
| |
c) Grants Repayable
As of September 30, 2024, the total grant balance repayable was $
For the Nine Months Ending September 30, 2024 |
| Amount |
| |
|
| $ |
| |
2024 - Remaining |
|
|
| |
2025 |
|
|
| |
2026 |
|
|
| |
2027 |
|
|
| |
2028 |
|
|
| |
Greater than 5 years |
|
|
| |
Total Grants Repayable |
|
|
| |
| 26 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
d) Long-Term Debt
As of September 30, 2024, the total balance for long-term debt payable was $
For the Nine Months Ending September 30, 2024 |
| Amount |
| |
|
| $ |
| |
2024 - Remaining |
|
|
| |
2025 |
|
|
| |
2026 |
|
|
| |
2027 |
|
|
| |
2028 |
|
|
| |
Greater than 5 years |
|
|
| |
Total |
|
|
| |
Less: amount representing interest |
|
| ( | ) |
Total Long-Term Debt |
|
|
| |
e) Collaborative Agreement Obligations
In 2018, the Company entered into a research collaboration agreement with the University of Taiwan for a
In 2022, the Company entered into a sponsored research agreement with The University of Texas MD Anderson Cancer Center to evaluate the role of neutrophil extracellular traps ("NETs") in cancer patients with sepsis for a cost to the Company of $
In July 2023, the Company entered into a research agreement with Xenetic Biosciences Inc and CLS Therapeutics Ltd to evaluate the anti-tumoral effects of Nu.Q® CAR T cells for a cost to the Company of $
In August 2023, the Company entered into a project research agreement with Guy’s and St Thomas’ NHS Foundation Trust to evaluate the practical clinical utility of the Nu.Q® H3.1 nucleosome levels in adult patients with sepsis to facilitate early diagnosis and prognostication for a cost to the Company of $
In January 2024, the Company entered into an agreement with the University Medical Centre Amsterdam (“UMC”). UMC will perform a retrospective study to evaluate the diagnostic potential of the Nu.Q® H3.1 nucleosomes as diagnostic, prognostic and phenotyping biomarkers in sepsis for a cost to the Company of $
| 27 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
e) Collaborative Agreement Obligations (continued)
As of September 30, 2024, the total amount to be paid for future research and collaboration commitments was $
|
| Total Amount Remaining |
|
| 2024 - Remaining |
|
| 2025 |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
National University of Taiwan |
|
|
|
|
|
|
|
|
| |||
MD Anderson Cancer Center |
|
|
|
|
|
|
|
|
| |||
Guys and St Thomas |
|
|
|
|
|
|
|
|
| |||
Xenetic Biosciences |
|
|
|
|
|
|
|
|
| |||
UMC |
|
|
|
|
|
|
|
|
| |||
Total Collaborative Obligations |
|
|
|
|
|
|
|
|
| |||
f) Other Commitments
Volition Germany
As of September 30, 2024, $
Volition America
Effective February 10, 2024 the Company and Diagnostic Oncology CRO, LLC (“DXOCRO”) further amended and restated the August 2022 amended and restated Master Agreement by and between the Company and DXOCRO to expand the scope of DXOCRO’s consultant services provided thereunder (the “Second A&R Master Agreement”). The Second A&R Master Agreement requires DXOCRO to conduct a prospective optimization/range finding study of Volition’s Nu.Q® H3.1 in vitro diagnostic test proposed for use in sepsis. The study is an extension of the sepsis monitoring clinical trial that was previously covered under a separate exhibit. The Company anticipates DXOCRO’s additional services
VolitionRx
On February 5, 2024, the Company entered into a
| 28 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 8 – Commitments and Contingencies (continued)
g) Legal Proceedings
In the ordinary course of business, the Company may be subject to claims, counter-claims, lawsuits and other litigation of the type that generally arise from the conduct of its business. The Company knows of 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
As of September 30, 2024, the Company has recognized total compensation expense of $
Total |
|
| Vesting |
| Amortized |
|
| Amortized |
|
| Amortized |
|
| Un-Amortized |
| |||||
Award |
|
| Year |
| 2024 |
|
| 2023 |
|
| 2022 |
|
|
|
| |||||
$ |
|
|
|
| $ |
|
| $ |
|
| $ |
|
| $ |
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||
In September 2023, the Compensation Committee of the Board of Directors of the Company approved the granting of cash bonuses, payable upon achievement of various corporate goals focused around revenue, operations and regulatory, to various personnel including directors, executives, members of management, consultants and employees of the Company and/or its subsidiaries. Pursuant to the terms of the grants, conditional upon the achievement by December 31, 2023 and June 30, 2024 of specified corporate goals as set forth in the minutes of the Compensation Committee, as well as continued service by the award recipients to the Company, the Company at the sole discretion of the Chief Executive Officer and the Chief Financial Officer would pay a cash bonus to such award recipients. As of September 30, 2024, the Company has accrued compensation expense of $
As of September 30, 2024, the Company had recognized total compensation expense of $
Total |
|
| Vesting |
| Amortized |
|
| Amortized |
|
| Un-Amortized |
| ||||
Award |
|
| Year |
| 2024 |
|
| 2023 |
|
| 2024 |
| ||||
$ |
|
|
|
| $ |
|
| $ |
|
| $ |
| ||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
|
| |||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
| 29 |
| Table of Contents |
VOLITIONRX LIMITED
Notes to the Condensed Consolidated Financial Statements (Unaudited)
($ expressed in United States Dollars)
Note 9 – Subsequent Events
Settlement of RSUs
On October 4, 2024,
RSUs Granted
Effective October 1, 2024, the Company granted RSUs of
Effective November 6, 2024, the Company granted aggregate RSUs of
Effective November 6, 2024, the Company granted aggregate RSUs of
Cancellation of Stock Options
On November 4 2024,
Long-Term Debt
On October 29, 2024, the Company entered into a
Appointment of Director and Non-Executive Chairman
On November 6, 2024 the Board, pursuant to the Company’s bylaws, passed a resolution to increase the size of the Board to eight (8) members and appointed Mr. Timothy I. Still to fill the new vacancy on the Board and fill the role of Non-Executive Chairman effective as of November 6, 2024. Mr. Still will have an initial term expiring at the Company’s 2025 annual meeting of stockholders, subject to his future nomination by the Nominations and Governance Committee and election by the Company’s stockholders. In connection with his appointment, Mr. Still and the Company entered into an Independent Director Agreement, pursuant to which Mr. Still will continue to serve as a member of the Board subject to any necessary approval by the Company’s stockholders as required by applicable law and the Company’s governing documents. In exchange for his services, pursuant to the terms of the Independent Director Agreement Mr. Still shall receive
END NOTES TO FINANCIALS
| 30 |
| 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. 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. It has patented technologies that use chromosomal structures, such as nucleosomes, and transcription factors as biomarkers in cancers and other diseases. The tests in the Company’s product portfolio detect certain characteristic changes that occur from the earliest stages of disease, enabling early detection and offering a better way to monitor disease progression and a patient’s response to treatment.
The tests offered by Volition and its subsidiaries are designed to diagnose and monitor a range of life-altering diseases, including certain cancers, and diseases associated with NETosis, such as sepsis. Early diagnosis and monitoring have the potential to not only prolong the life of patients but also improve their quality of life.
Our key pillars of focus are:
| · | Nu.Q® Vet - cost-effective, easy-to-use blood tests for dogs and other companion animals. The Nu.Q® Vet Cancer Test is commercially available as a cancer screening test in dogs. |
| · | Nu.Q® NETs - monitoring the immune system to save lives. |
| · | Nu.Q® Discover - a complete solution to profiling nucleosomes. |
| · | Nu.Q® Cancer - monitoring disease progression, response to treatment and minimal residual disease. |
| · | Capture-PCRTM - isolating and capturing circulating tumor derived DNA from plasma samples for early cancer detection. |
Commercialization Strategy
Our commercialization strategy is guided by the following underlying principles ensuring our products:
| · | Result in low capital expenditures for licensors and end users and low operating expenses for Volition, |
| · | Are affordable, and |
| · | Are accessible worldwide. |
The principles above inform our overall commercialization strategy for our products, which is driven by the following:
| · | Conducting research and development in-house and through our research partners; |
| · | Monetizing our intellectual property (“IP”) with upfront payments, milestone payments, royalties, and sales of kits and key components; and |
| · | Commercializing our products via global players and in fragmented markets through third party regional companies. |
We partner with established diagnostic companies to market, sell, and process our tests, leveraging their networks and expertise.
We believe, given the global prevalence of cancer and diseases associated with NETosis, and the low-cost, accessible and routine nature of our tests, they could potentially be used throughout the world.
We aim to remain an IP powerhouse in the epigenetic space and expect to monetize our IP and technologies through licensing and distribution contracts with companies that have established distribution networks and expertise on a worldwide or regional basis, in both human and animal care across platforms (centralized labs and point-of-care / in-house diagnostics).
| 31 |
| Table of Contents |
To this end, on March 28, 2022, Volition entered into a master license and product supply agreement with Heska Corporation (“Heska”). In exchange for granting Heska exclusive worldwide rights to sell our Nu.Q® Vet Cancer Test at the point of care for companion animals, Volition received a $10.0 million upfront payment upon signing, received $13.0 million based upon the achievement of two milestones and is eligible to receive up to an additional $5.0 million based upon the achievement of a final milestone upon the earlier of the first commercial sale by or on behalf of Heska of a screening or monitoring test for lymphoma in felines, or the nine-month anniversary of the first peer reviewed paper evidencing clinical utility for the screening or monitoring of lymphoma in felines being published in any one of a number of periodicals identified by the parties. In addition, Volition has granted Heska non-exclusive rights to sell the Nu.Q® Vet Cancer Test as a kit for companion animals through Heska’s network of central reference laboratories. In June 2023 Heska was acquired by Mars Petcare and became part of it’s Antech Diagnostics division. In April 2024, Antech announced the launch of the in-clinic version of the Nu.Q® Canine Cancer test in the US and Europe. During the nine months of 2024, Volition supplied key components for 105,000 tests to Antech.
In addition, in October 2022, we entered into a licensing and supply agreement with IDEXX Laboratories, Inc. (“IDEXX”), a global leader in pet healthcare innovation. This contract provides for worldwide customer reach through IDEXX’s global reference laboratory network as we continue to commercialize our transformational Nu.Q® technology within the companion animal healthcare sector and capitalize on the significant opportunities available. IDEXX launched the IDEXX Nu.Q® Canine Cancer Test in January 2023.
In November 2023, we launched the Nu.Q® Vet Cancer Test in the UK and Ireland through our distributor, the Veterinary Pathology Group, and in the UK through Nationwide Laboratories. In March 2024, Fujifilm Vet Systems announced the launch of the Nu.Q® Vet Cancer Test in Japan. In July 2024, VetLab announced the launch of the Nu.Q® Vet Cancer Test in Poland. The tests are now available in sixteen countries.
Liquidity and Capital Resources
We have financed our operations since inception primarily through private placements and public offerings of our common stock. As of September 30, 2024, we had cash and cash equivalents of approximately $5.4 million.
Net cash used in operating activities was $20.5 million for the nine months ended September 30, 2024 and $24.5 million for the nine months ended September 30, 2023. The decrease in cash used in operating activities for the period ended September 30, 2024 when compared to same period in 2023 can be attributed a reduction in clinical trial expenditure.
Net cash used in investing activities was $0.4 million and $0.8 million for the nine months ended September 30, 2024 and September 30, 2023, respectively. The decrease was mainly due to a reduction in purchases of laboratory equipment, partly offset by increased additions of licenses.
Net cash provided by financing activities was $6.4 million for the nine months ended September 30, 2024 and $25.2 million for the comparable period ended September 30, 2023. The decrease in cash provided by financing activities for the period ended September 30, 2024 when compared to same period in 2023 was primarily due to $17.6 million in net cash received from the issuance of shares of common stock in a registered public offering in June 2023, and $8.0 million in net cash received from the issuance of shares of common stock in a registered public offering in February 2023, as compared to $0.6 million in net cash received from the issuance of shares of common stock under our “at-the-market” facility during the period ended September 30, 2024 together with $6.3 million in net cash received from the issuance and sale of the shares of common stock, pre-funded warrants and the common warrants registered direct offering that closed in August 2024 with H.C. Wainwright & Co. acting as exclusive placement agent.
For additional information on our “at-the-market” facility, and the August 2024 registered direct offering, refer to Note 6, Common Stock –Equity Distribution Agreement, and 2024 Equity Capital Raise, of the notes to the condensed consolidated financial statements included within this Report.
| 32 |
| Table of Contents |
The following table summarizes our approximate contractual payments due by year as of September 30, 2024.
Approximate Payments (Including Interest) Due by Year | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
| Total |
|
| 2024 - Remaining |
|
| 2025 - 2028 |
| Greater than 5 years |
| ||||||
Description |
| $ |
|
| $ |
|
| $ |
|
| $ |
| ||||
Financing lease liabilities |
|
| 456,977 |
|
|
| 14,983 |
|
|
| 239,735 |
|
|
| 202,259 |
|
Operating lease liabilities and short-term lease |
|
| 757,350 |
|
|
| 89,033 |
|
|
| 668,317 |
|
|
| - |
|
Grants repayable |
|
| 454,544 |
|
|
| 27,857 |
|
|
| 187,971 |
|
|
| 238,716 |
|
Long-term debt |
|
| 5,883,097 |
|
|
| 551,774 |
|
|
| 5,004,472 |
|
|
| 326,851 |
|
Collaborative agreements obligations |
|
| 1,232,263 |
|
|
| 812,985 |
|
|
| 419,278 |
|
|
| - |
|
Total |
|
| 8,784,231 |
|
|
| 1,496,632 |
|
|
| 6,519,773 |
|
|
| 767,826 |
|
We intend to use our cash reserves to predominantly fund further research and development, and commercialization activities. We do not have any substantial source of revenues and expect to rely on additional future financing, through the sale of licensing or distribution rights, grant funding and the sale of equity or debt securities to provide sufficient funding to execute our strategic plan. There is no assurance that we will be successful in raising further funds.
In the event additional financing is delayed, we will prioritize the completion of clinical validation studies for the purpose of the sale of licensing or distribution rights, and the maintenance of our patent rights. In the event of an ongoing lack of financing, it may be necessary to discontinue operations, which will adversely affect the value of our common stock.
We have not attained profitable operations and are dependent upon obtaining financing to pursue any extensive activities. For these reasons, our auditors included in their report on our audited financial statements for the year ended December 31, 2023, an explanatory paragraph regarding factors that raise substantial doubt that we will be able to continue as a going concern. For additional information regarding our going concern assessment, refer to Note 2, Liquidity and Going Concern Assessment, of the notes to the condensed consolidated financial statements included within this Report.
| 33 |
| Table of Contents |
Results of Operations
Comparison of the Three Months Ended September 30, 2024 and September 30, 2023
The following table sets forth our results of operations for the three months ended September 30, 2024 and September 30, 2023.
|
| Three Months Ended September 30, |
|
|
|
|
|
|
| |||||||
|
| 2024 |
|
| 2023 |
|
| Change |
|
| Change |
| ||||
|
| $ |
|
| $ |
|
| $ |
|
| % |
| ||||
Service |
|
| 68,434 |
|
|
| 37,688 |
|
|
| 30,746 |
|
|
| 82 | % |
Product |
|
| 406,088 |
|
|
| 127,523 |
|
|
| 278,565 |
|
| >100 | % | |
Total Revenues |
|
| 474,522 |
|
|
| 165,211 |
|
|
| 309,311 |
|
| >100 | % | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
| 3,473,782 |
|
|
| 4,650,658 |
|
|
| (1,176,876 | ) |
| (25 | %) | |
General and administrative |
|
| 1,815,863 |
|
|
| 2,599,908 |
|
|
| (784,045 | ) |
| (30 | %) | |
Sales and marketing |
|
| 1,053,584 |
|
|
| 1,567,700 |
|
|
| (514,116 | ) |
| (33 | %) | |
Total Operating Expenses |
|
| 6,343,229 |
|
|
| 8,818,266 |
|
|
| (2,475,037 | ) |
| (28 | %) | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
| 85,378 |
|
|
| 48,656 |
|
|
| 36,722 |
|
|
| 75 | % |
Loss on disposal of fixed assets |
|
| (1,195 | ) |
|
| (15,913 | ) |
|
| 14,718 |
|
| (92 | %) | |
Interest income |
|
| 530 |
|
|
| 230 |
|
|
| 300 |
|
| >100 | % | |
Interest expense |
|
| (89,456 | ) |
|
| (53,980 | ) |
|
| (35,476 | ) |
|
| 66 | % |
Gain on change in fair value of warrant liability |
|
| 4,872 |
|
|
| 220,874 |
|
|
| (216,002 | ) |
| (98 | %) | |
Total Other Income (Expenses) |
|
| 129 |
|
|
| 199,867 |
|
|
| (199,738 | ) |
| (>100 | %) | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
| (5,868,578 | ) |
|
| (8,453,188 | ) |
|
| (2,584,610 | ) |
| (31 | %) | |
Revenues
Our operations are transitioning from a research and development stage to a commercialization stage. Revenues during the three-months ended September 30, 2024 were $474,522, compared with $165,211 for the three-months ended September 30, 2023. Our main source of revenues during the three months ended September 30, 2024 and September 30, 2023 was product revenues from sales of the Nu.Q® Vet Cancer Test. The year on year increase in revenues was primarily driven by sales of key components of the Nu.Q® Vet Cancer Test to Antech.
| 34 |
| Table of Contents |
Operating Expenses
Total operating expenses decreased to $6.3 million for the three months ended September 30, 2024 from $8.8 million for the three months ended September 30, 2023, as a result of the factors described below.
Research and Development Expenses
Research and development expenses decreased to $3.5 million from $4.7 million for the three-months ended September 30, 2024, and September 30, 2023, respectively. This decrease was primarily related to decreased personnel expenses, lower direct research and development expenses from reduced clinical trial activity and reduced stock-based compensation. The number of full-time equivalent (“FTE”) personnel we employed in this division decreased by 12 to 59 compared to the prior year period.
|
| Three Months Ended September 30, |
|
|
|
| ||||||
|
| 2024 |
|
| 2023 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 1,694,457 |
|
|
| 2,373,968 |
|
|
| (679,511 | ) |
Stock-based compensation |
|
| 49,643 |
|
|
| 162,651 |
|
|
| (113,008 | ) |
Direct research and development expenses |
|
| 984,541 |
|
|
| 1,677,977 |
|
|
| (693,436 | ) |
Other research and development |
|
| 464,762 |
|
|
| 148,033 |
|
|
| 316,729 |
|
Depreciation and amortization |
|
| 280,379 |
|
|
| 288,029 |
|
|
| (7,650 | ) |
Total research and development expenses |
|
| 3,473,782 |
|
|
| 4,650,658 |
|
|
| (1,176,876 | ) |
General and Administrative Expenses
General and administrative expenses decreased to $1.8 million from $2.6 million for the three-months ended September 30, 2024, and September 30, 2023, respectively. The reduction is due to lower personnel expenses and legal costs during the period. The FTE personnel number within this division decreased by 2 to 20 compared to the prior year period.
|
| Three Months Ended September 30, |
|
|
|
| ||||||
|
| 2024 |
|
| 2023 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 994,909 |
|
|
| 1,437,615 |
|
|
| (442,706 | ) |
Stock-based compensation |
|
| 217,334 |
|
|
| 214,833 |
|
|
| 2,501 |
|
Legal and professional fees |
|
| 260,586 |
|
|
| 517,955 |
|
|
| (257,369 | ) |
Other general and administrative |
|
| 302,663 |
|
|
| 368,047 |
|
|
| (65,384 | ) |
Depreciation and amortization |
|
| 40,371 |
|
|
| 61,458 |
|
|
| (21,087 | ) |
Total general and administrative expenses |
|
| 1,815,863 |
|
|
| 2,599,908 |
|
|
| (784,045 | ) |
Sales and Marketing Expenses
Sales and marketing expenses decreased to $1.1 million from $1.6 million for the three-months ended September 30, 2024, and September 30, 2023, respectively. The reduction is due to lower personnel expenses and stock-based compensation, partly offset by increased direct marketing and professional fees during the period. The FTE personnel number within this division decreased by 4 to 17 compared to the prior year period.
|
| Three Months Ended September 30, |
|
|
|
| ||||||
|
| 2024 |
|
| 2023 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 693,690 |
|
|
| 1,237,449 |
|
|
| (543,759 | ) |
Stock-based compensation |
|
| 56,562 |
|
|
| 160,496 |
|
|
| (103,934 | ) |
Direct marketing and professional fees |
|
| 291,268 |
|
|
| 156,775 |
|
|
| 134,493 |
|
Depreciation and amortization |
|
| 12,064 |
|
|
| 12,980 |
|
|
| (916 | ) |
Total sales and marketing expenses |
|
| 1,053,584 |
|
|
| 1,567,700 |
|
|
| (514,116 | ) |
| 35 |
| Table of Contents |
Other Income (Expenses)
For the three-months ended September 30, 2024, the Company’s other income was $129 compared to $199,867 for the three-months ended September 30, 2023. This decrease in other income was primarily due to a gain on change in fair value of warrants in the prior year period.
Net Loss
For the three months ended September 30, 2024, the Company’s net loss was approximately $5.9 million in comparison to a net loss of $8.5 million for the three months ended September 30, 2023. The change was primarily a result of reduced personnel costs and clinical trial activity, partly reflecting the completion of certain research and development projects.
Comparison of the Nine Months Ended September 30, 2024 and September 30, 2023
The following table sets forth our results of operations for the nine months ended September 30, 2024 and September 30, 2023:
|
| Nine Months Ended September 30, |
|
|
|
|
|
|
| |||||||
|
| 2024 |
|
| 2023 |
|
| Change |
|
| Change |
| ||||
|
| $ |
|
| $ |
|
| $ |
|
| % |
| ||||
Service |
|
| 155,713 |
|
|
| 93,207 |
|
|
| 62,506 |
|
|
| 67 | % |
Product |
|
| 886,141 |
|
|
| 438,122 |
|
|
| 448,019 |
|
| >100 | % | |
Total Revenues |
|
| 1,041,854 |
|
|
| 531,329 |
|
|
| 510,525 |
|
|
| 96 | % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
| 11,819,106 |
|
|
| 15,007,623 |
|
|
| (3,188,517 | ) |
| (21 | %) | |
General and administrative |
|
| 6,353,647 |
|
|
| 7,826,568 |
|
|
| (1,472,921 | ) |
| (19 | %) | |
Sales and marketing |
|
| 4,112,731 |
|
|
| 4,944,259 |
|
|
| (831,528 | ) |
| (17 | %) | |
Total Operating Expenses |
|
| 22,285,484 |
|
|
| 27,778,450 |
|
|
| (5,492,966 | ) |
| (20 | %) | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant income |
|
| 85,378 |
|
|
| 214,451 |
|
|
| (129,073 | ) |
| (60 | %) | |
Loss on disposal of fixed assets |
|
| (34,693 | ) |
|
| (15,913 | ) |
|
| (18,780 | ) |
| (>100 | %) | |
Interest income |
|
| 9,634 |
|
|
| 84,987 |
|
|
| (75,353 | ) |
| (89 | %) | |
Interest expense |
|
| (247,871 | ) |
|
| (163,623 | ) |
|
| (84,248 | ) |
|
| 51 | % |
Gain on change in fair value of warrant liability |
|
| 30,424 |
|
|
| 249,845 |
|
|
| (219,421 | ) |
| (88 | %) | |
Total Other Income (Expenses) |
|
| (157,128 | ) |
|
| 369,747 |
|
|
| (526,875 | ) |
| (>100 | %) | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
| (21,400,758 | ) |
|
| (26,877,374 | ) |
|
| (5,476,616 | ) |
| (20 | %) | |
Revenues
Our operations are transitioning from a research and development stage to a commercialization stage. Revenues during the nine-months ended September 30, 2024 were $1,041,854, compared with $531,329 for the nine-months ended September 30, 2023. Our main source of revenue during the nine-months ended September 30, 2024 and nine-months ended September 30, 2023 was product revenues from sales of the Nu.Q® Vet Cancer Test. The year on year increase in revenues was primarily driven by sales of key components of the Nu.Q® Vet Cancer Test to Antech and sales of Nu.Q® Discover services.
Operating Expenses
Total operating expenses decreased to $22.3 million from $27.8 million for the nine months ended September 30, 2024 and September 30, 2023, respectively, as a result of the factors described below.
| 36 |
| Table of Contents |
Research and Development Expenses
Research and development expenses decreased to $11.8 million for the nine months ended September 30, 2024, from $15.0 million for the nine months ended September 30, 2023. This decrease was primarily related to decreased direct research and development expenses as a result of reduced clinical trial activity with DXOCRO, reduced personnel expenses and reduced stock-based compensation. The FTE personnel number decreased by 12 to 59 compared to the prior year period.
|
| Nine Months Ended September 30, |
|
|
|
| ||||||
|
| 2024 |
|
| 2023 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 5,986,037 |
|
|
| 6,783,623 |
|
|
| (797,586 | ) |
Stock-based compensation |
|
| 212,217 |
|
|
| 455,125 |
|
|
| (242,908 | ) |
Direct research and development expenses |
|
| 3,822,868 |
|
|
| 6,240,312 |
|
|
| (2,417,444 | ) |
Other research and development |
|
| 980,462 |
|
|
| 700,654 |
|
|
| 279,808 |
|
Depreciation and amortization |
|
| 817,522 |
|
|
| 827,909 |
|
|
| (10,387 | ) |
Total research and development expenses |
|
| 11,819,106 |
|
|
| 15,007,623 |
|
|
| (3,188,517 | ) |
General and Administrative Expenses
General and administrative expenses decreased to $6.4 million from $7.8 million for the nine months ended September 30, 2024 and September 30, 2023, respectively. This decrease was primarily due to lower personnel expenses, stock-based compensation and legal and professional fees during the period. The FTE personnel number decreased by 2 to 20 compared to the prior year period.
|
| Nine Months Ended September 30, |
|
|
|
| ||||||
|
| 2024 |
|
| 2023 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 3,253,311 |
|
|
| 4,105,660 |
|
|
| (852,349 | ) |
Stock-based compensation |
|
| 512,096 |
|
|
| 777,482 |
|
|
| (265,386 | ) |
Legal and professional fees |
|
| 1,433,252 |
|
|
| 1,674,613 |
|
|
| (241,361 | ) |
Other general and administrative |
|
| 1,030,511 |
|
|
| 1,087,346 |
|
|
| (56,835 | ) |
Depreciation and amortization |
|
| 124,477 |
|
|
| 181,467 |
|
|
| (56,990 | ) |
Total general and administrative expenses |
|
| 6,353,647 |
|
|
| 7,826,568 |
|
|
| (1,472,921 | ) |
Sales and Marketing Expenses
Sales and marketing expenses decreased to $4.1 million compared to $4.9 million for the nine months ended September 30, 2024 and September 30, 2023. This decrease was due to reduced personnel expenses and stock-based compensation during the period. The FTE personnel number decreased by 4 to 17 compared to the prior year period.
|
| Nine Months Ended September 30, |
|
|
|
| ||||||
|
| 2024 |
|
| 2023 |
|
| Change |
| |||
|
| $ |
|
| $ |
|
| $ |
| |||
Personnel expenses |
|
| 3,150,406 |
|
|
| 3,674,191 |
|
|
| (523,785 | ) |
Stock-based compensation |
|
| 218,492 |
|
|
| 591,204 |
|
|
| (372,712 | ) |
Direct marketing and professional fees |
|
| 707,474 |
|
|
| 639,528 |
|
|
| 67,946 |
|
Depreciation and amortization |
|
| 36,359 |
|
|
| 39,336 |
|
|
| (2,977 | ) |
Total sales and marketing expenses |
|
| 4,112,731 |
|
|
| 4,944,259 |
|
|
| (831,528 | ) |
Other Income (Expenses)
For the nine months ended September 30, 2024, the Company’s other expenses were $157,128 compared to other income of $369,747 for the nine months ended September 30, 2023. The increase in other expenses is due to increased interest paid partly offset by a reduction in grant income, interest received and a gain on change in fair value of warrants in the prior year period.
| 37 |
| Table of Contents |
Net Loss
For the nine months ended September 30, 2024, the Company’s net loss was approximately $21.4 million in comparison to a net loss of $26.9 million for the nine months ended September 30, 2023. The change was primarily a result of reduced clinical trial activity and personnel costs.
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
There have been no material changes to our 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 our Equity Distribution Agreement with Jefferies LLC or through other equity or debt financings. See Note 6, Common Stock – Equity Distribution Agreement, of the notes to the condensed consolidated financial statements. However, we may be unable to obtain such additional capital when needed, or on terms favorable to us or our stockholders, if at all. If we raise additional funds by issuing equity securities, the percentage ownership of our stockholders will be reduced, stockholders may experience additional dilution, or such equity securities may provide for rights, preferences or privileges senior to those of the holders of our common stock. If additional funds are raised through the issuance of debt securities, the terms of such securities may place restrictions on our ability to operate our business.
Critical Accounting Policies and Estimates
Our interim condensed consolidated financial statements and accompanying notes have been prepared in accordance with United States generally accepted accounting principles, (“GAAP”), applied on a consistent basis. The preparation of financial statements in conformity with 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 also regularly evaluate 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, valuations of stock-based compensation and deferred revenue.
We base our estimates and assumptions on current facts, historical experiences, information from third party professionals and various other factors that we believe 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. Actual results may differ materially and adversely from our estimates. To the extent there are material differences between the estimates and the actual results, future results of operations could be affected.
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. There have been no material changes to the critical accounting policies and key estimates and assumptions disclosed in the section titled “Critical Accounting Policies and Estimates” in Part II, Item 7 within our Annual Report.
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.
| 38 |
| Table of Contents |
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company and are not required to disclose this information.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Disclosure controls and procedures are controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by our company in the reports that it files or submits under the Exchange Act is accumulated and communicated to our management, including our Principal Executive and Principal Financial Officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Our management carried out an evaluation, under the supervision and with the participation of our Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer have concluded, as they previously concluded as of December 31, 2023, that our disclosure controls and procedures were not effective as of September 30, 2024, 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.
We identified a material weakness in our internal controls over financial reporting. In particular we do not have sufficient written documentation of our internal control policies and procedures, including written policies and procedures to ensure the correct application of accounting and financial reporting with respect to the current requirements of GAAP and SEC disclosure requirements.
Notwithstanding the material weakness, we believe that our financial statements contained in this Report fairly present our financial position, results of operations and cash flows for the periods covered by this Report in all material respects.
Our management, with the oversight of our audit committee, has initiated steps and plans to take additional measures to remediate the underlying causes of the material weakness, which we currently believe will be primarily through revising precision level management review controls and gaining additional assurance regarding our outside service providers’ quality control procedures. It is possible that we may determine that additional remediation steps will be necessary in the future.
| 39 |
| Table of Contents |
Planned Remediation of Material Weakness
Our management has been actively engaged in developing and implementing remediation plans to address material weakness described above. These remediation efforts are ongoing and include or are expected to include:
| · | engaging internal control consultants to assist us in performing a financial reporting risk assessment as well as identifying and designing our system of internal controls necessary to mitigate the risks identified; |
|
|
|
| · | preparation of written documentation of our internal control policies and procedures; |
|
|
|
| · | increasing personnel resources and technical accounting expertise within the accounting function to replace our outside service providers; and |
|
|
|
| · | until we have sufficient technical accounting resources, we have engaged external consultants to provide support and to assist us in our evaluation of more complex applications of GAAP. |
We continue to enhance corporate oversight over process-level controls and structures to ensure that there is appropriate assignment of authority, responsibility, and accountability to enable remediation of our material weakness. We believe that our remediation plan will be sufficient to remediate the identified material weakness and strengthen our internal control over financial reporting. As we continue to evaluate, and work to improve, our internal control over financial reporting, management may determine that additional measures to address control deficiencies or modifications to the remediation plan are necessary.
Changes in Internal Control over Financial Reporting
Except for the ongoing remediation of the material weakness in internal controls over financial reporting noted above, no changes in our internal control over financial reporting were made during the nine months ended September 30, 2024, 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.
| 40 |
| Table of Contents |
PART II OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
In the ordinary course of business, we may be subject to claims, counter claims, lawsuits and other litigation of the type that generally arise from the conduct of our business. We know of no material, existing or pending legal proceedings against our company, nor are we involved as a plaintiff in any material proceeding or pending litigation. There are no proceedings in which our directors, officers or any affiliates, or any registered or beneficial stockholders, is an adverse party or has a material interest adverse to our interest.
ITEM 1A. RISK FACTORS
There have been no material changes in our assessment of risk factors affecting our business since those presented in Part I, Item 1A of our Annual Report.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Recent Sales of Unregistered Securities
None.
Repurchase of Equity Securities
No equity securities were repurchased during the third quarter of 2024.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
None.
| 41 |
| Table of Contents |
ITEM 6. EXHIBITS
|
|
|
| Incorporated by Reference |
|
| ||||||
Exhibit Number |
| Exhibit Description |
| Form |
| File No. |
| Exhibit |
| Filing Date |
| Filed Herewith |
| Second Amended and Restated Certificate of Incorporation, as amended and currently in effect. |
| S-8 |
| 333-280974 |
| 4.2 |
| 7/24/24 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Amended and Restated Bylaws, as amended and currently in effect. |
| 10-Q |
| 001-36833 |
| 3.2 |
| 5/13/24 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 8-K |
| 001-36833 |
| 4.1 |
| 8/12/24 |
|
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 8-K |
| 001-36833 |
| 4.2 |
| 8/12/24 |
|
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 8-K |
| 001-36833 |
| 4.3 |
| 8/12/24 |
|
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 8-K |
| 001-36833 |
| 10.1 |
| 7/3/24 |
|
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
| Form of Notice of Stock Option Grant and Stock Option Agreement under the 2024 Stock Incentive Plan. |
| S-8 |
| 333-280974 |
| 99.1(a) |
| 7/24/24 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| S-8 |
| 333-280974 |
| 99.1(b) |
| 7/24/24 |
|
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| S-8 |
| 333-280974 |
| 99.1(c) |
| 7/24/24 |
|
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| S-8 |
| 333-280974 |
| 99.1(d) |
| 7/24/24 |
|
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| S-8 |
| 333-280974 |
| 99.1(e) |
| 7/24/24 |
|
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| S-8 |
| 333-280974 |
| 99.1(f) |
| 7/24/24 |
|
| ||
| 42 |
| Table of Contents |
|
| 8-K |
| 001-36833 |
| 10.1 |
| 8/12/24 |
|
| ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| X | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| X | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| X | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| X | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| X | ||
|
|
|
|
|
|
|
|
|
|
|
|
|
101.INS |
| Inline XBRL Instance Document. |
|
|
|
|
|
|
|
|
| X |
|
|
|
|
|
|
|
|
|
|
|
|
|
101.SCH |
| Inline XBRL Taxonomy Extension Schema Document. |
|
|
|
|
|
|
|
|
| X |
|
|
|
|
|
|
|
|
|
|
|
|
|
101.CAL |
| Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
|
|
|
|
|
|
|
|
| X |
|
|
|
|
|
|
|
|
|
|
|
|
|
101.LAB |
| Inline XBRL Taxonomy Extension Label Linkbase Document. |
|
|
|
|
|
|
|
|
| X |
|
|
|
|
|
|
|
|
|
|
|
|
|
101.PRE |
| Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
|
|
|
|
|
|
|
|
| X |
|
|
|
|
|
|
|
|
|
|
|
|
|
101.DEF |
| Inline XBRL Taxonomy Extension Definition Linkbase Document. |
|
|
|
|
|
|
|
|
| X |
|
|
|
|
|
|
|
|
|
|
|
|
|
104 |
| Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
|
|
|
|
|
|
|
|
| X |
# | Indicates a management contract or compensatory plan or arrangement. |
|
|
† | Portions of this exhibit are redacted pursuant to Item 601(a)(6) and/or Item 601(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. |
| 43 |
| Table of Contents |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| VOLITIONRX LIMITED |
| |
|
|
|
|
|
|
|
|
Dated: November 14, 2024 | By: | /s/ Cameron Reynolds |
|
Cameron Reynolds |
| ||
President and Chief Executive Officer (Authorized Signatory and Principal Executive Officer) |
| ||
| |||
| |||
| |||
Dated: November 14, 2024 | By: | /s/ Terig Hughes |
|
Terig Hughes |
| ||
Chief Financial Officer and Treasurer (Authorized Signatory and Principal Financial and Accounting Officer) |
| ||
| 44 |