Cameron Reynolds
Analyst · Cantor Fitzgerald
Thanks, Terig. I'm delighted with the progress we are making and in particular, could not be prouder of the team's achievements this quarter in advancing our product pillars. Our first pillar to discuss on this call is Nu.Q NET. During the second quarter, we secured a CE Mark for Nu.Q NET for the detection and evaluation of NETosis enabling clinical use in more than 27 countries across Europe. As a reminder, NETosis is a unique form of ChLIA that is characterized by the release of Neutrophil Extracellular Traps or NET composed of de-condensed chromatin that trap and kill bacteria and viral particles. Although NET play an important role in our immune system, excessive production can lead to tissue damage and in severe cases, sepsis, shock and death. Through routine blood test, Volition's simple, low-cost, accessible technology can detect NETosis, predict disease severity and monitor it's progression and response to treatment. Nu.Q NET is the first biomarker approved to measure NET for patient management. Its broad intended use as a diagnostic tool to aid the detection and evaluation of diseases associated with NETosis offers a substantial commercial opportunity, as discussed at our Capital Markets Day we held in New York in May. We estimate that the total addressable market in Europe, per sepsis alone amounts to almost $6.5 billion annually. Achieving CE Marking is a critical regulatory milestone for us. Nu.Q NET is now rented for use in Europe in both ELISA, which are the plastic plates and automated ChLIA, which is ChemiLuminescence automatic assay formats. The Commercial team have now commenced a market access program with key European opinion leaders and early adopters and expect to drive sales from the first half of next year in 2023. Subsequent to quarter end, momentum continued for the Nu.Q NET pillar, starting with new publications. In collaboration with research at the University of Namur, QUALIblood in Belgium, we published a paper entitled, NETosis and Nucleosome Biomarkers in Septic Shock and Critical COVID-19 Patients: An Observational Study. We also presented a poster entitled, Evaluation and comparison of NETosis biomarkers in sepsis and COVID-19 patients at the International Society on Thrombosis and Hemostasis, ISTH, Congress in July. The ISTH conference was a real highlight of the year to date with many of the team in attendance to [ manage the booth ] and develop a network of key opinion leaders and potential licensing and distribution partners. We also sponsored a GenomeWeb webinar presented by Dr. Andrew Aswani of Guy's and St Thomas' Hospital titled, The Promise of Neutrophil Extracellular Traps (NETs) as Biomarkers in Inflammatory Disease. This webinar, the second series, was incredibly well attended with an engaged audience. Indeed, the share of the meeting that it was the most questions he could remember them ever receiving so certainly interest remains high in this emerging field of medicine. To watch on-demand visit the GenomeWeb website. And last, but certainly no means least, we are delighted to announce some new clinical studies for NETs with MD Anderson and with Diagnostics Oncology CRO or DXO for short, both in the U.S. We're delighted to be working with one of the world's leading cancer research institutions, MD Anderson. Cancer patients have a weakened immune system and shockingly have a 10x higher likelihood of developing sepsis and are more likely to die if they develop it. Therefore, it is critical for physicians to identify cancellations at risk of sepsis early and initiate treatment quickly to improve patient outcomes. Our study with MD Anderson is an important study that evaluates the potential utility of using Nu.Q NETs in the management of cancer patients at risk of sepsis and we're delighted to collaborate on this research. This week, we appointed clinical research organization, DXOCRO, to undertake development and clinical validation of studies for our Nu.Q product portfolio in the U.S. 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. We anticipate that subsequent studies will investigate the chosen intended use claims in the test with the objective to gain clearance, authorization or approval from the United States Food and Drug Administration, or the FDA, and allows the test to be marketed in the U.S. These multisite development studies will help us demonstrate how our new cytomics technology can directly benefit patients and support our application to the FDA's breakthrough device program by year-end and a pre-submission anticipated in 2023. My thanks to Sharon Ballesteros and Gaetan Michel for spearheading our research efforts in the U.S. It's fantastic to get this project underway. So a truly exciting few months for Nu.Q NETs. Great to achieve the EU regulatory hurdle and start our marketing access program in earnest and equally fantastic to get our clinical and regulatory program underway in the U.S. And from one exciting pillar to another, Nu.Q Vet. I'll now pass over to Dr. Tom Butera, our Chief Executive Officer of our Veterinary subsidiary for his update.