VolitionRX Ltd., a life sciences company focused on developing blood-based diagnostic tests, today issued the following letter to its shareholders from Cameron Reynolds, CEO.
Dear Shareholders,
Given the speed at which our company has been growing and the fact that we have been reaching our key milestones, I would like to review the past year and look forward to future goals that will continue to make the Company successful. We have had an extremely productive year establishing the structural basics of the Company, and in the past seven months, focusing on the development and marketing of our innovative and ground-breaking suite of NuQ products.
A technology is only as good as the team that runs it, and I must say I am extremely happy with who we are as a Company and with every one of our personnel. We began placing our team in 2010 by forming a new Board which brought together a strong mix of business and scientific leaders, including Dr. Martin C. Faulkes, our Chairman. Dr. Faulkes was also behind the creation of the Volition foundation to support charitable research to help fulfil our corporate social responsibilities. We have also appointed our world-class Scientific Advisory Board, chaired by Dr. Alan Colman, who meet quarterly to provide valuable top-level direction for our Chief Scientific Officers (Dr. Micallef and Dr. Eccleston). Amongst the four members of the Scientific Advisory Board are the two original inventors of Volition’s key technologies, who are based at world-renowned institutions. During this period we also put together a very committed group of key scientists based in our lab in Belgium who have produced consistently strong results for us.
We have also had a very solid year on the funding side, having received both equity investments and government financial assistance totalling over $3.3 million. I would like to particularly thank the Wallonian Government in Belgium, whose support allowed us to open our laboratory at the Unite de Recherche en Biologie Cellulaire – FUNDP in Namur, Belgium. This lab has proved to be invaluable for speedy proof of concepts, scientific focus, and product development. We have seen extremely promising results coming out of our lab in recent months, and in September we announced the filing of three new patents. We now hold five Nucleosomics™ patent applications, one granted and four pending (two patent applications are licensed from external sources – the European Molecular Biology Laboratory and Chroma Therapeutics Limited – and three are Volition-authored). We also hold a HyperGenomics™ patent application which is licensed from Imperial College London and an application for a patent for a test for endometriosis, which is also based on our Nucleosomics™ technology. We believe we will file several more patents as our team continues to make breakthroughs.
We have also made applications to register trademarks in the U.S. and Europe for our key technologies to give us the basis for the branding of our products.
We have also made progress in our currently non-core technologies, HyperGenomics™ and Endometriosis, and will focus on developing these technologies in early 2012 once we have our NuQ products on the market. We have created a separate subsidiary, HyperGenomics Pte Limited, to allow HyperGenomics to develop separately from our core products. We anticipate that we will finalize the development plans for the subsidiary in Q1 of 2012 assuming the results of testing underway are positive.
The team has been working hard validating cancer samples using our Nucleosomics™ tests and we have seen extremely promising results to date. Our NuQ-X™ test for the detection of nucleosomes containing specific nucleotides have shown 100% accuracy in cancer patients, and our NuQ-V™ tests for the detection of nucleosomes containing specific histone variants (which identify the type of cancer present) have shown 85% accuracy identifying cancer, in a small number of blood samples from both healthy and cancer patients. The early results are extremely encouraging, and the next step is to test the NuQ suite of products on hundreds and then thousands of samples through the end of this year and next. We have also been very successful in identifying and procuring a range of antibodies that are key to our NuQ test and have several under development to be ready in Q1 next year.
Over the next few months we will beta-test our first NuQ products with several selected external independent laboratories who have agreed to test our kits to provide feedback on their efficacy and usability. Following on from the beta-testing period we will begin to offer the kits for sale to research institutions. In early 2012 we will anticipate being able to commence full clinical trials for CE Marking (European regulatory approval), and are currently finalizing members of our Clinical Trials Management Committee, which we intend to announce this year, which will drive Volition’s Clinical Trials strategy. We are also in discussions with a couple of major Companies with a view to getting a comprehensive marketing agreement by Q3 of next year.
Additionally, we are focusing on the marketing of our first Nucleosomics™ research products, which are expected to be available to the market by Q1 2012. We anticipate applying for CE Marking in 2012 and then for FDA approval by the end of 2013. We believe that the in vitro nature of our products will allow quicker regulatory approval than the vast majority of therapeutics.
In closing, the past year has been an extremely exciting time for Volition, culminating in our being quoted this month on the OTC Bulletin Board in the United States of America. We look forward to the next 12 months, which we believe will be equally exciting, as we move towards truly revolutionizing cancer diagnostics.
Thank you all for your continued support.
Sincerely,
Cameron Reynolds
CEO, VolitionRX Limited
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