On August 10, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the second quarter ended June 30, 2022 (Press release, VolitionRX, AUG 10, 2022, View Source [SID1234618049]). Volition management will host a conference call tomorrow, August 11 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details can be found below.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I am delighted with the progress we are making, and in particular could not be prouder of the team’s achievement in securing a CE Mark for Nu.Q NETs in Europe and in announcing new clinical studies for NETosis, or NETs, in the U.S. with both MD Anderson and with Diagnostic Oncology CRO LLC, or DXOCRO. As the only analytically validated test for NETs currently available, we believe that there is enormous potential for Nu.Q NETs to support clinical decision-making, enabling physicians to act quickly, and improve patient outcomes," commented Cameron Reynolds, President and Chief Executive Officer of Volition.

"Following the execution of our global licensing and supply agreement for the Nu.Q Vet Cancer Screening Test with Heska Corporation, the team has been hard at work with the technology transfer program and launch preparation. We also continue to make good progress with other potential licensing and supply partners. Finally, we have recently executed a number of contracts for Nu.Q Discover."

Company Highlights

Financial

Cash and cash equivalents as of June 30, 2022, totaled approximately $16.7 million compared with $20.6 million as of December 31, 2021.
Subsequent to quarter end, Volition received approximately $6.4 million net of underwriter’s fees and expenses in cash through an underwritten public offering of its common stock that closed on August 2.
Secured a further $1.5 million in non-dilutive funding from Namur Invest Capital Risk in Belgium to fund an early access program for Volition’s Nu.Q product portfolio at key sites across the EU, UK, and U.S.
Continued to manage expenditures carefully with net cash used in operating activities averaging approximately $2.1 million per month in the quarter.
Personnel/ Operational

Appointed Sharon Ballesteros as U.S. Head of Quality and Development Process to spearhead Volition’s clinical product development program in the U.S. and expanded her team and operations in California.
Nu.Q NETs

Nu.Q NETs test has been CE marked for the detection and evaluation of NETosis, enabling clinical use in Europe in both ELISA (enzyme-linked immunoassay) and automated ChLIA (ChemiLuminescence ImmunoAssay) formats.
Announced a sponsored research agreement with The University of Texas MD Anderson Cancer Center to evaluate the role of NETS in cancer patients with sepsis.
Appointed DXOCRO to undertake development and clinical validation studies for Volition’s Nu.Q product portfolio in the United States.
DXOCRO will conduct large-scale finding studies across multiple sites in the U.S. using Volition’s Nu.Q NETs and Nu.Q Cancer tests to determine clinical utility in sepsis and cancer.
Volition anticipates that subsequent studies will investigate the chosen intended use claims of the tests, with the objective to gain clearance, authorization, or approval from the United States Food and Drug Administration (the "FDA") and allow the tests to be marketed in the U.S.
These multi-site development studies will help demonstrate how Volition’s Nucleosomics technology can directly benefit patients and support our application to the FDA’s Breakthrough Devices Program and a Pre-submission anticipated in 2023.
In collaboration with researchers at the University of Namur and QUALIblood in Belgium, published:
a clinical paper entitled "NETosis and Nucleosome Biomarkers in Septic Shock and Critical COVID-19 Patients: An Observational Study", and
a poster presentation entitled "Evaluation and comparison of NETosis biomarkers in sepsis and COVID-19 patients" at the International Society on Thrombosis and Haemostasis (ISTH) Congress in July.
Subsequent to quarter end, sponsored a GenomeWeb webinar titled ‘The Promise of Neutrophil Extracellular Traps (NETs) as Biomarkers in Inflammatory Disease’. To watch on demand, visit the GenomeWeb website.
Commenced a Market Access Program with European Key Opinion Leaders and early adopters.
Volition Veterinary

Following the execution of a global licensing and supply agreement with one of the industry’s leading companies, Heska Corporation, started the technology transfer and launch preparations with Heska.
SAGE Healthcare launched the Nu.Q Vet Cancer Test in Singapore.
Advanced negotiations with other potential licensing and supply partners in efforts to make Nu.Q Vet products as accessible as possible worldwide and anticipate further announcements in 2022.
Expanded product claims with the presentation of new clinical data at:
the European Society of Veterinary Oncology Congress in May. To view click here.
the American College of Veterinary Internal Medicine (ACVIM) in June. To view click here.
Expanded access to a larger clinical research laboratory at Texas A&M University and appointed a veterinary emergency criticalist to commence work in non-cancer indications in addition to developing our clinical research network in Europe.
Nu.Q Capture

Nu.Q Capture, when used in combination with either sequencing, mass spectrometry and/or Volition’s Nu.Q assays could potentially aid diagnosis, treatment selection, and both treatment and disease monitoring in addition to aiding biomarker discovery.
The Nu.Q Capture program now has several strands of technology which:
essentially remove background noise, thereby amplifying the signal,
look to identify the signal in a novel way including through mass spectrometry, or
isolate various chromatin fragments, including nucleosomes and transcription factors.
Sponsored a GenomeWeb webinar entitled "Novel Proteomics Approach to Epigenetic Profiling of Circulating Nucleosomes" featuring Professor Axel Imhof. To watch on demand, visit the GenomeWeb website.
Nu.Q Discover

Progressing projects with a range of customers.
Recently signed contracts with three bio-pharmaceutical companies who are accessing our assay portfolio for rapid epigenetic profiling of their drugs in development.
Upcoming Priorities

Drive near term revenue in the following key areas:
Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet.
Complete Heska Corporation agreement milestones in order to receive further milestone payments.
Sales of key components of Point of Care test with Heska.
Sales of kits from non-exclusive agreements for the use of Nu.Q Vet via central reference labs.
Ongoing and new Nu.Q Discover agreements.
Sales of its disease monitoring tests (e.g. COVID-19, sepsis).
Continue to progress the research program for the use of Nu.Q NETs, in monitoring disease progression of COVID-19, sepsis, and potentially other diseases and as a possible companion diagnostic for the treatment of sepsis.
Continue to advance its previously announced large-scale blood, lung, and colorectal cancer trials in Europe, Asia, and the U.S.
Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of its Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend its intellectual property portfolio.

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations of Volition. The call will provide an update on important events which have taken place in the second quarter of 2022 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 View Source In addition, a telephone replay of the call will be available until August 25, 2022. 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 13732149.