VolitionRx Limited Announces Third Quarter 2019 Financial Results and Business Update

On November 12, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the third quarter ended September 30, 2019 (Press release, VolitionRX, NOV 12, 2019, View Source [SID1234551013]). Volition management will host a conference call tomorrow, November 13, at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results, commented, "I could not be more proud of our dedicated team at Volition, and the ground-breaking work we are doing. I’m happy to say that we have made excellent progress this quarter on our platform development, Nu.Q Capture, Nu.Q Vet and our colorectal cancer and lung cancer trials, particularly in Asia, and we reported our first revenues from sales of Research Use Only kits and the provision of contract research services.

We are an epigenetics company focused on advancing the science of epigenetics and exploiting these advances in human and animal health. This has been our mission since our founding, and it is coming to fruition with our Nu.Q platform at the very heart of epigenetics. We believe the last decade of work and our extensive intellectual property portfolio puts Volition in a strong position to be a significant player in this field by launching multiple products."

Click here to view an interview with Volition’s Chief Executive Officer.

Mr. Reynolds further commented, "We aim to strengthen our product pipeline beyond colorectal cancer to cover several cancers, most notably in lung cancer, and so are especially delighted to have commenced two studies in lung cancer this quarter, firstly our large-scale study in lung cancer with the National Taiwan University and secondly our first study in China with Shanghai Fosun Long March Medical Science Co. Ltd. We have also expanded our colorectal cancer work with a first trial in China underway with Fosun.

"I am also delighted to announce that subsequent to quarter end we executed a contract with Texas A&M University to collaborate on the research and development of Nu.Q Vet products and help drive early revenue in the all-important veterinary market."

Additionally, Mr. Reynolds added, "During the third quarter 2019, we further strengthened our balance sheet with an existing investor exercising $4.8 million in aggregate amount of outstanding warrants to purchase shares of our common stock making a total of $16.5 million in warrants exercised during the first three quarters of 2019 and ended the quarter with cash and cash equivalents of $19.7 million. During the third quarter we were awarded a further $1.4 million in non-dilutive grant-funding from the Walloon Region and, subsequent to quarter end, an additional $500,000 unsecured loan from SOFINEX was approved. We also recorded our first revenues this quarter from sales of our Research Use Only kits and the provision of services."

Company Highlights

Financial

Cash and cash equivalents as of September 30, 2019 totaled $19.7 million compared to $13.4 million as of the end of 2018.
Recorded first revenues from the sales of our Research Use Only kits and from the provision of sample processing services to a third party.
Continued to manage cash carefully with an average quarterly cash burn rate over the first three quarters of 2019 of approximately $3.6 million.
Clinical Trials

Commenced our first large-scale lung cancer study in conjunction with the prestigious National Taiwan University ("NTU"). The study is being conducted under the supervision of Professor Chen Jin-Shing in the Department of Surgery of NTU and will include 1,200 subjects receiving Low-Dose Computed Tomography scans. We expect the first data from this trial in the first half of 2020.
Commenced our first studies in China for both lung and colorectal cancer with Shanghai Fosun Long March Medical Science Co. Ltd.
Organizational

Completed the formation of a U.S.-based majority-owned subsidiary, Volition Veterinary Diagnostics Development LLC, to drive the development and commercialization of Nu.Q Vet products and appointed its Chief Executive Officer, Mr. Nathan Dewsbury.
Executed agreements with Texas A&M University’s College of Veterinary Medicine to collaborate on the research and development of Nu.Q Vet products.
Made strong progress in platform development, including the appointment of a Clinical Validation Expert with more than 15 years of experience in adapting assays to automated machines to greatly broaden our product platform range.
Intellectual Property

Achieved steady growth in our worldwide patent portfolio. We believe that this is a key differentiator versus many other technologies either under development or available on the market, where the patent position may be poor and/or narrow.
20 patent families related to our diagnostic tests (including both human and veterinary medicine applications).
8 patents granted in the United States.
7 patents granted in the European Union.
25 further patents granted worldwide.
106 patents pending worldwide.
Upcoming Milestones

We expect to achieve the following milestones during 2019 and through 2020:

Announce the results of multiple proof of concept cancer studies, starting in December 2019 and continuing throughout 2020.
Complete the CE Marking of IVD kits for cancer triage tests.
Advance our previously announced large-scale colorectal and lung cancer trials with a significant number of assays on the highly analytically accurate automated platform(s).
Announce preliminary results of Nu.Q’s performance in other disease conditions.
Advance the development of Nu.Q Capture by determining the level of discrimination of tumor associated nucleosomes using immunoassays and sequencing.
Through Volition Veterinary and the collaboration with Texas A&M, complete the pre-analytical and discovery studies to determine and announce the route to revenue for Nu.Q Vet products.
Submit abstracts and clinical papers for publication from our Nucleosomics work in a wide range of areas.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts. I, along with the rest of the Board and indeed the whole company, look forward to sharing our progress and the results of key studies over the remainder of 2019 and throughout 2020."

For further details please contact [email protected].

VolitionRx Limited Third Quarter 2019 Earnings
and Business Update Conference Call

Date: Wednesday, November 13, 2019
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: 13696533
Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations. The call will provide an update on recent developments and Volition’s activities, including details of new and ongoing clinical trials, important events which have taken place in the third quarter of 2019, and milestones for 2019 and beyond.

Boston Scientific Completes €900 million Offering of Senior Notes and $1.0 billion Tender Offer

On November 12, 2019 Boston Scientific Corporation (NYSE: BSX) (the "Company") reported a public offering of €900.0 million aggregate principal amount of 0.625% Senior Notes due 2027 (the "Notes") (Press release, Boston Scientific, NOV 12, 2019, View Source [SID1234551012]). The Company has applied to list the Notes on the New York Stock Exchange.

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In addition, the Company completed its previously announced cash tender offer (the "Tender Offer") for up to $1.0 billion aggregate principal amount of certain outstanding senior notes, pursuant to which it accepted $206,429,000, $566,455,000, and $227,117,000 of tendered principal amounts of its 4.125% Senior Notes due 2023, 4.000% Senior Notes due 2028 and 3.850% Senior Notes due 2025, respectively on the early settlement date.

The Company used the net proceeds from the offering to (i) fund the Tender Offer and (ii) pay accrued and unpaid interest, premiums, fees and expenses in connection with the Tender Offer.

Laboratory for Advanced Medicine Presents New Liver Cancer Test Data at The Liver Meeting 2019

On November 12, 2019 Laboratory for Advanced Medicine, an AI-driven healthcare company focused on commercializing early cancer detection tests from a simple blood draw, reported that it will be presenting new data supporting its methylation-based liver cancer diagnostic test at The Liver Meeting 2019 hosted by the American Association for the Study of Liver Diseases (AASLD), taking place in Boston from Nov. 8-12 (Press release, Laboratory for Advanced Medicine, NOV 12, 2019, View Source [SID1234551011]). AASLD selected Laboratory for Advanced Medicine’s data for poster presentation as a "Poster of Distinction." Posters of Distinction are classified as being in the top 10% of scored poster abstracts.

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Data from the presentation, titled "A DNA Methylation-Based Diagnostic Platform: Towards Early Detection of Hepatocellular Carcinoma," suggests that using the DNA methylation panel for hepatocellular carcinoma (HCC) provides superior performance than the current standard of care screening methods such as ultrasound and alpha-fetoprotein. This analysis evaluated blood samples from 450 subjects by using DNA methylation technology which correctly detected HCC in patients for an overall sensitivity of 88% (n= 218/249) and correctly identified 96% of healthy donors (n= 80/83) and 98% of patients with benign disease (n=116/118) with a combined specificity of 97%.

"These results highlight the importance of continued development and validation of blood-based DNA methylation biomarkers for detecting liver cancer early," said Dhruvajyoti Roy, PhD, Director of Technology at LAM. "The new results and continued validations strongly support Laboratory for Advanced Medicine’s ongoing clinical trial to evaluate the performance of the liver cancer test for the detection of HCC within a high risk population."

AASLD Poster Presentation Details:

Abstract Number: 0843

Abstract Title: "A DNA METHYLATION-BASED DIAGNOSTIC PLATFORM: TOWARDS EARLY DETECTION OF HEPATOCELLULAR CARCINOMA"

Location: Hynes Convention Center, Hall B

Poster Session Date: Saturday, November 9, 2019

Poster Session Time: 2:00 PM – 7:00 PM

AbbVie Prices $30 Billion of Senior Unsecured Notes

On November 12, 2019 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported that it has priced its previously announced private offering (the "Offering") of senior unsecured notes in a combined aggregate principal amount of $30 billion (collectively, the "Notes") (Press release, AbbVie, NOV 12, 2019, View Source [SID1234551010]). The Notes will be issued in ten tranches: (i) $750,000,000 in aggregate principal amount of senior floating rate notes due May 2021, (ii) $750,000,000 in aggregate principal amount of senior floating rate notes due November 2021, (iii) $750,000,000 in aggregate principal amount of senior floating rate notes due 2022, (iv) $1,750,000,000 in aggregate principal amount of 2.150% senior notes due 2021, (v) $3,000,000,000 in aggregate principal amount of 2.300% senior notes due 2022, (vi) $3,750,000,000 in aggregate principal amount of 2.600% senior notes due 2024, (vii) $4,000,000,000 in aggregate principal amount of 2.950% senior notes due 2026, (viii) $5,500,000,000 in aggregate principal amount of 3.200% senior notes due 2029, (ix) $4,000,000,000 in aggregate principal amount of 4.050% senior notes due 2039 and (x) $5,750,000,000 in aggregate principal amount of 4.250% senior notes due 2049. AbbVie expects that the closing of the Offering will occur on November 21, 2019, subject to the satisfaction of customary closing conditions.

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The Offering is being conducted in connection with AbbVie’s previously announced acquisition (the "Acquisition") of Allergan plc ("Allergan"). AbbVie expects to use the net proceeds from the Offering to fund a portion of the aggregate cash consideration due to Allergan shareholders in connection with the Acquisition and to pay related fees and expenses, with any remaining net proceeds being used for general corporate purposes. The Offering is not conditioned upon the consummation of the Acquisition. However, if (i) the Acquisition has not been consummated on or prior to January 30, 2021 or (ii) prior to such date, AbbVie notifies the trustee in respect of the Notes that it will not pursue the consummation of the Acquisition, then AbbVie will be required to redeem all of the Notes then outstanding at a special mandatory redemption price equal to 101% of the aggregate principal amount of the Notes, plus accrued and unpaid interest, if any, to, but not including, the applicable special mandatory redemption date.

The Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), any state securities laws or the securities laws of any other jurisdiction, and may not be offered or sold in the United States, or for the benefit of U.S. persons, except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities or blue sky laws. Accordingly, the Notes are being offered in the United States only to persons reasonably believed to be "qualified institutional buyers," as that term is defined under Rule 144A of the Securities Act, or outside the United States to non-"U.S. persons" in accordance with Regulation S under the Securities Act.

A confidential offering memorandum for the Offering of the Notes has been made available to such eligible persons. The Offering is being conducted in accordance with the terms and subject to the conditions set forth in such confidential offering memorandum.

This news release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, the Notes or any other security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful.

Personalis, Inc. Expands Oncology Portfolio With the Launch of Cancer Whole Genome Sequencing Services

On November 12, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the launch of Personalis’ Cancer Whole Genome Sequencing which further extends Personalis’ portfolio of comprehensive cancer genomics services designed to maximize biological insights from tumor samples (Press release, Personalis, NOV 12, 2019, View Source [SID1234551009]).

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"This new offering continues our push to provide our customers genomics solutions that enable deeper insights into patient responses to oncology therapies," said John West, CEO of Personalis. "We are uniquely poised to provide a leading cancer whole genome sequencing solution which combines Personalis’ deep technology and experience in analyzing cancer samples for biopharma oncology clinical trials and the large-scale laboratory and data systems developed for the VA MVP program, one of the largest whole genome sequencing programs in the world."

Earlier this year, Personalis was awarded a new task order under its contract with the U.S. Department of Veterans Affairs (VA) for the VA Million Veteran Program (VA MVP). This order brought the cumulative scale of orders received to date from the VA MVP to over 110,000 human genomes. Since 2013, Personalis has sequenced over 40,000 MVP samples. Personalis anticipates it will sequence the additional samples over the coming years as they are received from the VA.

"As our understanding of the complexity of underlying mechanisms of cancer grows, it is becoming increasingly important to evaluate genome-wide structural variants, and other forms of non-coding genetic variation," commented Dr. Richard Chen, CSO of Personalis. "This new service advances our position at the leading edge of cancer translational research with biopharma customers."