Cameron Reynolds
Analyst · Maxim Group. Please proceed with your question
Thank you everyone for joining Volition’s conference call today. I'm happy to say we have great momentum and have made progress on many fronts this year in platform development with Nu.Q Capture, our colorectal and lung cancer work, our Asian trials, and of course with Nu.Q Vet. Firstly, let me start by reiterating our vision and what makes us so excited with our progress and our space. Since the human genome was published in 2001, there have been tremendous advances in DNA sequencing technology. Billions of dollars have been spent by several well-known companies, and a wide range of research groups, and great strides have been made in sequencing cancer mutations for drug treatment selection. However, there appears to now be a growing realization that the DNA sequence is only one part of the picture and it is unlikely, for example, to be clinically useful for early cancer detection in many cancers. DNA does not occur in isolation, but exists in cells as chromosomes made up of DNA and proteins in nucleosomes. The DNA essentially forms the recipe book for making all human proteins. But like all recipe books, we don't make every recipe every day. Some recipes are made often and others rarely, some are never made. The DNA recipes are just the same and which protein dishes are made when is determined by the epigenetics type of the chromosomes. Many human diseases, including cancer, are caused by a loss of normal chromosomal epigenetic regulations. VolitionRx is an epigenetics company, focused on advancing the science of epigenetics and exploring these advances in human health. This has been our mission since our founding, and it's coming to fruition with our Nu.Q platform at the very heart of epigenetics. So we say, the epigenetics is as, if not more, important than the genetics, the DNA. In short, it's not DNA, it's the full chromosome. We strongly believe the last decade of work at VolitionRx with our ever expanding team in epigenetics, puts VolitionRx in an extremely strong position with our expansive IP portfolio to be a significant player in this key field. Overall I'm delighted with our progress we are making and I'm excited by the momentum we have. We have spent a great deal of effort over the last two years developing our assays to final product grade with many improvements including monoclonal antibodies and using recombinant nucleosomes as calibrants, something that was implausible just a few years ago and is now routine in our assays. As of today, we have now utilized two of our finalized Nu.Q assays in eight separate discovery cohorts across the five cancers and can confirm they have performed well in all studies to-date, demonstrating its reproducibility and robust nature on manipulate, [ph] the simplest platform. And so, I'm delighted to announce that with regards to our traditional play [ph], we are now in the process of CE Marking some of our finalized assays so that our IBD kit can then be used in both human and animal clinical trials. In parallel, in order to ensure our tests are accessible around the world, we have also undertaken broader work on automated platforms which are based on chemiluminescence and magnetic beads, a format which is used by all the leading global diagnostic companies, such as Roche, Abbott, et cetera, as well as a large range of smaller open platforms. These platforms are also on the very basic ELISA platform. To expedite this, we are delighted to announce that a clinical validation expert on these automotive platforms with more than 15 years experience in the industry has recently joined our Belgium team. This assay transfer project has allowed us to work on cutting edge AutoAnalyzer platforms from both Europe and China. Indeed we believe we are the first lab to be operating the [indiscernible] AutoAnalyzer outside China. Not only has this opened up a number of ELISA platforms that our technology can be operated on in the market, but also and perhaps even more importantly, the adaptation to automation platforms based on chemiluminescence and magnetic beads has significantly increased the analytical accuracy of our assays by a factor of more than tenfold. We will now utilize these bead based assays in our clinical studies including our large scale clinical trial program such as the colorectal and lung cancer studies collected in Taiwan. I am also delighted to announce that we have received our first revenues from both our first research only kit sales and from the service contract processing samples with our nuclear research kits. The results from the samples that we processed under contract were promising and will be published next year. This is yet again, progress momentum in yet another area of our business. Also this quarter, we were delighted to announce a significant milestone in our Nu.Q Capture development program. The ability to enrich nucleosomes and therefore DNA of tumor versus non-tumor origin by separating long from short nucleosomes. This breakthough could be used in a number of ways. Firstly, by using mass spectrometry, new biomarker targets may be discovered. Secondly, and importantly, as an enabling technology, in sequence based liquid biopsies by enriching the nucleosomes of cancer origin from the blood. And lastly, to increase specificity in VolitionRx's assays by moving the background signal. I am extremely excited that this enabling technology could bridge the gap between VolitionRx's epigenetic profiling approach to early detection and the sequencing approaches that have so far been limited to personalized treatment selection. These recent results, could impact the entire sector and highlight VolitionRx as a leader in the field of clinical epigenetics. The next step in our Nu.Q Capsure developmental work which is underway and we will be reporting in the coming months, is to determine the level of discrimination to achievement derive nucleosomes using immunoassays and sequencing to provide a complete analysis of [indiscernible] nucleosomes. Overall, our R&D team has made remarkable progress while keeping our cash burn right low and consistent with prior quarters. Thanks must go to Dr. Gaetan Michel and all the Belgium team for their continuing efforts. And so, to the all important financials this quarter. We closed out the third quarter of 2019 with $19.7 million in cash and cash equivalents versus $13.4 million at the year-end of last year. During the third quarter, a longstanding investor exercised $4.8 million in aggregate amount of outstanding warrants to purchase shares of our common stock, bringing the total cash received by the company upon exercise of warrants by existing shareholders in 2019 to date to $16.5 million, showing very strong shareholder support. I am also delighted to announce that subsequent to quarter end we further strengthened our balance sheet with some additional nondilutive funding from the SOFINEX fund in Belgium. We are also really proud to be able to have done all of our work with the consistent quarterly cash burn right throughout 2019 of approximately $3.6 million per quarter. We continue to manage cash carefully and believe that we are at a very sound position with regards to the financial runway to achieve our 2019 and 2020 key milestones. During the third quarter, we were delighted that the National Taiwan University commenced our first large-scale lung cancer study which will include 1200 subjects receiving Low-Dose Computed Tomography scans at a total cost of approximately $320,000 payable over two years. This study demonstrates once more VolitionRx's commitment to conducting large yet cost effective trials worldwide. We are hopeful that our recent proof-of-concept results in lung cancer will be repeated in this much larger cohort and expect to release preliminary data relating to the initial 600 patients in the first half of 2020 and the remainder by the end of next year. We were also excited to have executed a contract with Shanghai Fosun Long March Medical Science Co. Ltd to introduce the new key platform to China. Based on our recent promising proof-of-concept data, using product made from Nu.Q assays the parties initially started a lung cancer study and have already expanded to collect colorectal samples and we are working together on the new [indiscernible] platform that I mentioned earlier. I am traveling out to the Far East later this month with Dr. Jasmine Kway, Singapore VolitionRx's Chief Executive Officer and are very much looking forward to continuing our discussions with the Fosun team. We were happy this quarter to have completed the formation and commenced operations of our new majority owned Texas based subsidiary, VolitionRx Vet Diagnostic Development LLC and welcome its Chief Executive Officer, Nathan Dewsbury to our team. VolitionRx Veterinary will focus on the further development and commercialization of Nu.Q Vet products and helped driver early revenue for the company. On the Veterinary front, subsequent to the quarter end, we were also delighted to execute a contract with Texas, A&M University to collaborate on the research and development of our Nu.Q Vet product in the all important veterinary market and things are moving fast. Last month in October, Dr. Heather Wilson-Robles, Associate Professor at Texas A&M presented pre-analytical data at the Veterinary Cancer Society Annual Conference in Houston. The VCS Conference is one of the largest Veterinary, oncology meetings in the world. The presentation was well received and generated much interest in the potential of new Nu.Q Vet. Also in October, I along with other Members of the Board and Executive Team, visited Texas A&M to sign the contract, memorializing the collaboration between VolitionRx and Texas A&M in the veterinary market. And I have to say we are incredibly impressed with both the facility and the team we will be working with to bring Nu.Q Vet products to market. A video capturing some of the trip is available on our website. On the intellectual property front, our worldwide portfolio of granted patents that protects various aspects of VolitionRx's Nu.Q technology is growing steadily. This is yet another key differentiator with many other technologies under development or available in the market. And I would like to thank Dr. Jake Micallef, our Chief Scientific Officer for his outstanding work in writing all of these patents. We have 20 patent families related to our diagnostic tests with 8 patents granted in the United States, 7 patents granted in the European Union, and a further 25 patents granted worldwide. Additionally, we have 15 patent applications in the name of our subsidiaries pending in the U.S. and 13 such patent applications in the European Union. This portfolio also covers veterinary medical applications. We intend to continue our pioneering work in the field of epigenetics through the development of our proprietary Neucleosomics [ph] technologies and will continue to apply for patents for future product developments. Our strategy is to protect our technologies and gain market exclusivity with patents in Europe and the United States and in other strategy countries. We believe that the patents on the technologies underlying our products should provide broad coverage for each product including protection through at least 2031. And finally, to future milestones, as the assay development program has gone so well, we can now return to our lung and colorectal cancer trials with a range of assays on an automated platform in early 2020, starting with medium sized studies before moving on to our large scale flagship trials. We expect to report the first of this data in the first half of next year. We are stepping up the work on these trials and preparations for abstract submissions for upcoming scientific conferences are underway and we expect to submit at least one clinical paper for publication in the coming months. In addition, we have been working on several proof-of-concept studies, the first data from which we will be realizing later this year. The need for simple, easy to use, cost effective test for cancer is truly universal and we hope very much that our Nu.Q tests can help revolutionize the way cancer is diagnosed worldwide. We are excited about the commencement of our work in China and look forward to completing the studies and to a successful collaboration with Fosun Long March. We have also begun the process of CE marking for Europe and registration in key Asian markets for our first lung and colorectal cancer triage products and we'll provide further details on this in the coming months. The development of Nu.Q Vet is picking up pace and we are hopeful to announce data and indeed present at upcoming conferences throughout 2020, beginning in the first quarter an aim to launch our first Nu.Q Vet product in the second half of next year. We look forward to announcing the next and hopefully final step in demonstrating the clinical utility of Nu.Q Capture for both sequencing and in our immunoassay approach in the first half of next year. Our whole team, including our Finance Advisory Board who met just last week are incredibly excited by the opportunities this represents. We aim with our solid cash position to report throughout 2020 and beyond several key milestones, including Nu.Q's ability to detect a range of cancers in both humans and animals, including preliminary data from our first studies in China in addition to clinical data on Nu.Q Capture. We are delighted to be working with collaborators from around the world, all of whom have outstanding reputations and share our aim in improving early diagnosis of cancer and other diseases. VolitionRx is 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. Remember, it is not DNA, it is the full chromosome that is important. We believe the last decade of work in epigenetics puts VolitionRx in an extremely strong position with our expansive IP portfolio to be significant player in this field. We also intend to further strengthen our supply chain for key components by bringing them in-house. We are extremely proud of the accomplishments we have achieved thus far and look forward to what the future holds for VolitionRx. I, along with the rest of board and indeed the whole company look forward to sharing the results of key studies over the coming year with our optimized platform. We expect 2020 to be our most exciting year yes. Thanks for joining the call today. I very much appreciate it, given the busy earnings cold season, we are happy to take your question. Operator?