0001477932-23-008448.txt : 20231114 0001477932-23-008448.hdr.sgml : 20231114 20231114161609 ACCESSION NUMBER: 0001477932-23-008448 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20231114 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231114 DATE AS OF CHANGE: 20231114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VOLITIONRX LTD CENTRAL INDEX KEY: 0000093314 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 911949078 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36833 FILM NUMBER: 231406506 BUSINESS ADDRESS: STREET 1: 1489 WEST WARM SPRINGS ROAD STREET 2: SUITE 110 CITY: HENDERSON STATE: NV ZIP: 89014 BUSINESS PHONE: 1 (646) 650-1351 MAIL ADDRESS: STREET 1: 1489 WEST WARM SPRINGS ROAD STREET 2: SUITE 110 CITY: HENDERSON STATE: NV ZIP: 89014 FORMER COMPANY: FORMER CONFORMED NAME: STANDARD CAPITAL CORP DATE OF NAME CHANGE: 19990812 8-K 1 vnrx_8k.htm FORM 8-K vnrx_8k.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(d) OF

THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): November 14, 2023

 

VOLITIONRX LIMITED

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-36833

 

91-1949078

(State or other jurisdiction

 

(Commission File Number)

 

(IRS Employer

of Incorporation)

 

 

Identification Number)

 

1489 West Warm Springs Road, Suite 110

Henderson, Nevada 89014

(Address of principal executive offices and Zip Code)

 

+1 (646) 650-1351

(Registrant’s telephone number, including area code )

 

Not applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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

 

Title of Each Class

 

Trading Symbol(s)

 

Name of Each Exchange on which Registered

Common Stock,par value $0.001 per share

 

VNRX

 

NYSE American, LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of  the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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. ☐

 

 

 

 

VOLITIONRX LIMITED

Form 8-K

Current Report

 

Item 2.02. Results of Operations and Financial Condition.

 

The following information, including Exhibit 99.1, is being “furnished” in accordance with General Instruction B.2. of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

On November 14, 2023, VolitionRx Limited (the “Company”) issued a press release announcing its financial results and certain business updates for the quarter ended September 30, 2023. The Company also confirmed its conference call to be held on November 15, 2023 at 8:30 a.m. U.S. Eastern Time. Furnished herewith as Exhibit 99.1 and incorporated by reference herein is a copy of the press release.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit

Number

 

 

Description

99.1

 

Press Release of VolitionRx Limited, dated November 14, 2023.

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL (eXtensible Business Reporting Language) document)

 

 
2

 

 

SIGNATURE

 

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

 

 

VOLITIONRX LIMITED

 

 

 

 

Date: November 14, 2023

By:

/s/ Cameron Reynolds

 

 

Cameron Reynolds

 

 

 

Chief Executive Officer & President

 

 

 
3

 

 

EXHIBIT INDEX

 

Exhibit

Number

 

 

Description

99.1

 

Press Release of VolitionRx Limited, dated November 14, 2023.

 

 
4

 

 EX-99.1 2 vnrx_ex991.htm PRESS RELEASE vnrx_ex991.htm

EXHIBIT 99.1

 

VolitionRx Limited Announces Third Quarter 2023 Financial Results and Business Update

 

Conference call to discuss financial and operational results scheduled for

Wednesday, November 15, at 8:30 a.m. U.S. Eastern Time

 

Henderson, Nevada, November 14, 2023 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”) today announced financial results and a business update for the third quarter ended September 30, 2023. Volition management will host a conference call tomorrow, November 15 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details can be found below.

 

Cameron Reynolds, President and Group Chief Executive Officer at Volition, commented:

 

“I am pleased to report that in the first nine months of 2023 revenue for the Nu.Q® Vet Cancer Test grew almost five-fold over the prior year period, reflecting sales of the reference kits through our global, regional and local supply agreements. Additionally, total year-to-date revenue was $531,000, a 185% increase compared to the comparable period of 2022. We believe that these results demonstrate steady growth, but not yet the “ramp” in revenues that we anticipate. We expect revenues to accelerate as we close out 2023 and into the early part of 2024 as several additional distributors come online with our Nu.Q® Vet Test.

 

“We continued to make considerable progress with our Nu.Q® NETs pillar. Most recently, we completed the Q-Sub process with the U.S. Food and Drug Administration, and we are happy to announce that they have agreed to the regulatory pathway of a traditional 510(k) with an adjudicated clinical comparator. We are grateful for the opportunity to participate in the Q-Sub process and appreciate the feedback we have received. The interactions were engaging and helpful and we feel gave us a clear regulatory path we need to follow for this potentially exciting opportunity.

 

“We hosted our first Key Opinion Leader Roundtable Event focused on sepsis in September and published an expert-led report. We also presented new data at the ESICM congress in Milan in October and were featured in a peer-reviewed publication from one of our Centers of Excellence in Europe.

 

“In October, we unveiled what we believe to be an entirely new cancer detection method at ESMO 2023, the annual congress of the European Society for Medical Oncology, and hosted a webinar detailing this transformational method. The results to date are exciting and we are now developing a range of cancer-specific assays which we expect to be more accurate than these preliminary results, and look forward to sharing our progress beginning in the first quarter of 2024. We believe that this opportunity is significant, and we have been encouraged by the level of interest shown by a range of leading diagnostic and liquid biopsy companies following ESMO.

 

“I am also delighted in the progress we are making to ensure our Nu.Q® Vet Cancer Test is accessible worldwide, with our recent launch in the UK and Ireland through two leading local companies; NationWide Laboratories and Veterinary Pathology Group. We anticipate launches in additional markets in Asia in the coming months.”

 

 
1

 

 

An interview with Cameron Reynolds, President and Group Chief Executive Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Terig Hughes, Group Chief Financial Officer of Volition.

https://youtu.be/c9tZu65VVA4

 

Financial Highlights

 

·

 Cash and cash equivalents as of September 30, 2023, totaled approximately $10.8 million compared with $10.9 million at the end of 2022.

·

 Subsequent to quarter end, a Walloon institutional fund and regional government bodies of the Walloon Region of Belgium approved providing additional funding to the company aggregating approximately $6 million. We expect the funding transactions to close this month.

·

 Expect to receive a further $13 million in milestone payments from Heska Corporation in the coming months.

 

 
2

 

 

Event: VolitionRx Limited Third Quarter 2023 Earnings and Business Update Conference Call

Date: Wednesday, November 15, 2023

Time: 8:30 a.m. U.S. Eastern Time

 

U.S. & Canada Dial-in: 1-877-407-9716 (toll free)

U.K. Dial-in: 0 800 756 3429 (toll free)

Toll/International: 1-201-493-6779

Conference ID: 13742634

 

Cameron Reynolds, President and Group Chief Executive Officer of Volition, will host the call along with Terig Hughes, Group Chief Financial Officer, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, Dr. Andrew Retter, Medical Consultant to Volition and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on important events which have taken place in the third quarter of 2023 and upcoming milestones.

 

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at https://ir.volition.com. In addition, a telephone replay of the call will be available until November 29, 2023. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13742634.

 

 

 

About Volition

 

Volition is a multi-national epigenetics company focused on advancing the science of epigenetics. Volition is dedicated to saving lives and improving outcomes for people and animals with life-altering diseases through earlier detection, as well as disease and treatment monitoring.

 

Through its subsidiaries, Volition is developing and commercializing simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of diseases, including some 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.

 

Volition’s research and development activities are centered in Belgium, with an innovation laboratory and office in the U.S. and additional offices in London and Singapore.

 

The contents found at Volition’s website address are not incorporated by reference into this document and should not be considered part of this document. Such website address is included in this document as an inactive textual reference only.

 

Media Enquiries:

 

Louise Batchelor/Debra Daglish, Volition, mediarelations@volition.com +44 (0)7557 774620

 

 
3

 

 

Safe Harbor Statement

 

Statements in this press release may be “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as “expects,” “anticipates,” “intends,” “plans,” “aims,” “targets,” “believes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” “suggests,” “could,” “would,” “should,” “may,” “will” and similar expressions identify forward-looking statements. These forward-looking statements relate to, among other topics, Volition’s expectations related to the revenue opportunities and launches of product sales with Heska and other counterparties to agreements, the timing, completion, success and delivery of data from clinical studies, the receipt of additional funding, the potential uses, benefits and effectiveness of its technology platforms, including the Nu.Q® NETs test and the Nu.Q® Vet Cancer Test, and the timing and execution of Volition’s strategy with the FDA. Volition’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties, including, without limitation, results of studies testing the efficacy of its tests; a failure by the marketplace to accept Volition’s Nu.Q® NETs test, Nu.Q® Vet Cancer Test or other products based on its technology platforms; Volition’s failure to secure adequate intellectual property protection; Volition’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products; Volition will face fierce competition and its intended products may become obsolete due to the highly competitive nature of the diagnostics and disease monitoring markets and their rapid technological change; downturns in domestic and foreign economies; and other risks, including those identified in Volition’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. For instance, if Volition fails to develop and commercialize diagnostic, prognostic or disease monitoring products, it may be unable to execute its plan of operations. Forward-looking statements are based on current expectations, estimates and projections about Volition’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

 

Nu.Q® and its logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners. Additionally, unless otherwise specified, all references to “$” refer to the legal currency of the United States of America.

 

 
4

 

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