Cameron Reynolds
Analyst · Maxim Group
Thanks, Terig. And thank you, Tom for those comprehensive updates. Great progress indeed. I will wrap up the call today with updates on two other product pillars, Nu.Q NETs and Nu.Q Cancer. Early in the third quarter and highlighted on our last call, we sponsored a GenomeWeb presented by Dr. Andrew Aswani at Guy’s and St Thomas' University Hospital London, titled, The Promise of Neutrophil Extracellular Traps, NETS as Biomarkers in Inflammatory Disease. This webinar is the second in a series was incredibly well attended with an engaged audience. To watch on demand, visit the GenomeWeb website. Also during the third quarter in collaboration with researchers at the University of Namur, and PolyBlood in Belgium, we published a clinical paper entitled NETosis and Nucleosome Biomarkers in Septic Shock and Critical COVID-19 Patients and Observational Studies, and a poster presentation entitled Evaluation and Comparison of NETosis Biomarkers in Sepsis and COVID-19 patients. At the International Society on Thrombosis and Hemostasis, ISDH Congress in July. Subsequent to the quarter end, we also presented data at the International Symposium on infection in the critically ill patients and international sepsis forum. The key findings presented are that levels of NETosis, as measured by our Nu.Q NETs test, are highly elevated in sepsis. And moreover, that the results of our tests correlate very well with the severity of disease. The severity of the disease is currently assessed using the sequential organ failure assessment SOFA score. This score is assessed on six separate organ functions , lung, cardiovascular, liver, kidney, the coagulation system, and the brain, our test results just a single number from a routine blood test correlated with the SOFA score, with something of great interest to the clinicians in attendance at the forum. These conferences were a real highlight of 2022 with many of the team in attendance to develop a network of key opinion leaders in addition to starting discussions with potential licensing and distribution partners. Indeed, I'm happy to announce we have initiated commercial discussions with major actors in the NETosis, and are making great progress with a market access program. We currently have two centers of excellence that actively using Nu.Q units with the further two deepen legal review of contractual terms. And we have identified a number of other sites we hope to onboard during 2023. These multiple centers of excellence will help narrow down specific indications useful to our future commercial partners, and regulatory trials. And speaking of trials, during the third quarter, we appointed clinical research organizations DXOCRO to undertake development and clinical validation studies of our Nu.Q product portfolio in the US. DXOCRO will conduct large scale finding studies across multiple sites in the US using Volition’s Nu.Q NETs and Nu.Q Cancer Test to determine clinical utility in sepsis and cancer. I'm very happy to say they've made significant progress in setting up sites with all three clinical studies. And I'm delighted to announce today, we anticipate our first patients been recruited into the study in the coming weeks. We anticipate that subsequent studies will investigate the chosen intended use claims of the test with the objective to gain clearance, authorization or approval in the United States Food and Drug Administration, the FDA and allow the test to be marketed in the US. These multisite studies will help us demonstrate how an Nucleosomics technology can directly benefit patients and support our application to the FDA breakthrough device program expected in the first half of next year, and a pre submission also anticipated in 2023. My great thanks to Sharon Ballesteros and the team was spearheading our research efforts in the US. It is fantastic to get this project underway. We're also delighted to be working with one of the world's leading cancer research institutions MD Anderson. As announced earlier in the third quarter, we are sponsoring research with the University of Texas MD Anderson Cancer Center for evaluate the role of Neutrophil Extracellular Traps, NETS in cancer patients with sepsis. Cancer patients have a weakened immune system, and shockingly have a 10 times higher likelihood of developing sepsis, and are also more likely to die if they develop it. Therefore, it is critical for physicians and underplay cancer patients 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 using Nu.Q NETs in the management of cancer patients at risk of sepsis. And we're delighted to collaborate on this research and look forward to sharing further updates and results in the future. And lastly, and bring us right up to date with the news out last week. We have been invited to participate in a government backed prospective study to evaluate the performance of blood biomarkers in the early detection of lung cancer with a Hospices Civils de Lyon, HCL, France’s second largest university hospitals, the Lyonnais is initiative for the Initiation of Lung Cancer Screening, ILYAD is a wide-ranging clinical study assessing the visibility of a lung cancer screening program and the effectiveness of screening. The ILYAD study will evaluate the performance of Volition’s Nu.Q test as a biomarker for the early detection of lung cancer, when used alone, and in conjunction with a CT scan over the next year. Lung cancer is tragically the most common cause of cancer deaths worldwide, with 1.8 million cases each year. We know that screening saves lives and there's a real unmet need for lung cancer screening globally. Our colleagues at HCL have recognized the need and we're proud to be part of their pioneering ILYAD study in France with the ultimate goal of developing a national screening program. It's expected that over 400 subjects will take part of the study over the next year, encompassing a smoking cessation and lung cancer awareness campaign, one on one intervention and screening opportunities. And indeed, I'm delighted to report the first 20 subjects have already been recruited. So truly, an exciting quarter here at volition for Nu.Q NETs with the achievement of our EU regulatory hurdle, publishing compelling data, staring our market access program in earnest. And indeed, our commercial discussions with major players in this space is also fantastic to get our clinical and regulatory program underway in the US, and commenced the government back study into lung cancer screening in France. After many years of hard work, the crawler has indeed delivered our rocket to the launch pad. And we're excited to have our Nu.Q Vet Cancer Test available, or soon to be available by five global and local licensing and supply agreements. I'm absolutely delighted with the progress we have made in the key pillar of the business as we progress strongly from a purely research and development company to a company with wide ranging products. It is an exciting fast-moving part of our business with clear potential to generate significant revenue for the company in terms of both milestone payments, and an ongoing revenue stream as some explained for the sale of kits and key components not only to healthcare and [inaudible] but also to Sage Healthcare in Singapore, Texas GI Lab, DNAtech in Portugal, and another global market leader in pet healthcare recently announced. And during this call, we're close I'd like to thank you all for joining us today. I along with the rest of the board and indeed the whole company very much look forward to sharing further news regarding Nu.Q Vet and other new key pillars, as well as the results of our key clinical studies, publications and milestones over the coming months and borders. I very much feel we're an extremely strong position to commercialize our Nu.Q platform in so many areas. Volition is truly is powered by Nu.Q. I cannot be more positive about our work at the heart of epigenetics. And I'm excited for the next phase of our journey. I'm happy to take questions. Operator?