WEB NEWS Comments & Business Outlook
AUSTIN, Texas, May 7, 2020 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced financial results and a business update for the first quarter ended March 31, 2020. Volition management will host a conference call tomorrow, May 8 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.
Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results commented, "During the first quarter, we, together with our collaborators, have made very strong progress, particularly in assay and platform development, with our Nu.QTM Capture program and epigenetic toolkit, Nu.QTM Vet in collaboration with Texas A&M University and, at the start of the year with the acquisition of the epigenetics reagents company, Octamer GmbH. Our team has done an amazing job completing all these milestones in these difficult times."
Company Highlights
Clinical – COVID-19
A proof of concept study involving 34 polymerase chain reaction (PCR) COVID-19 positive subjects and 50 control subjects revealed that nucleosomes were highly elevated in the PCR positive subjects.
Clinical- Veterinary
In a proof of concept study conducted by Texas A&M University, a single Nu.QTM Vet assay detected almost 70% of both Canine Hemangiosarcoma and Canine Lymphoma with AUCs of 84.5% and 83.1% cancer versus healthy, respectively, at a specificity of 90%. These two cancers alone represent almost a third of all canine cancers.
Abstract Publications
Three of Volition's abstracts have been accepted for publication by ASCO (American Society of Clinical Oncology) and are expected to be publicly released on Wednesday, May 13.
Assay Development
Volition has completely re-engineered its Nu.QTM assays to now use a magnetic particle-based assay format leading to a step-change improvement in analytical performance which Volition expects to translate into improved clinical performance.
Epigenetic Toolbox
Volition has developed and is seeking patents on its novel Nu.QTM Capture-based epigenetic tools. Volition is using these tools to expand diagnostic developments that focus on circulating DNA fragment analysis, leading to a broader and potentially more powerful investigation of the epigenetic status of a patient's circulating chromosome fragments, in addition to its ongoing work with its assay-based format in a range of cancers. Volition expects additional data on this in the coming months.
Organization
Volition completed the acquisition of its epigenetics reagents subsidiary, Octamer GmbH (renamed Volition Germany GmbH), in the first quarter of 2020.
Financial
Cash and cash equivalents as of March 31, 2020 totalled approximately $12 million.
Upcoming Milestones
Volition expects to achieve the following milestones during 2020 and beyond:
Release a range of clinical data from COVID-19 studies currently underway.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts especially given the challenging circumstances we all face during the COVID-19 pandemic. I, along with the rest of the Board and indeed the whole company, look forward to sharing the results of key studies over the coming year."
As a result of the COVID-19 pandemic during the first quarter of 2020, Volition implemented contingency planning to protect the health and well-being of its employees, with most employees working remotely where possible. Its laboratory in Belgium has remained open with the attendance of its dedicated laboratory technicians who have kept its research and development work on track with Volition's expectations. Many of its small and medium sized studies have already been collected and their samples stored at its onsite biobank so the trial work underway and planned for the first half of 2020 is still tracking expectations. Regarding its large-scale studies, both the colorectal cancer and lung cancer studies underway in Taiwan are still ongoing with collection, however the study collection in the U.S. with the EDRN has been paused during the pandemic. The overall timing impact of the EDRN collection pause on the study is unknown at this stage, however, Volition will provide an update once the study re-commences.
Comments & Business Outlook
AUSTIN, Texas, Jan. 13, 2020 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today provided an update on its Nu Q™ Clinical Assays which use a magnetic particle-based assay format. Volition has completely re-engineered its Nu.Q™ assays leading to a step-change improvement in analytical performance. Volition expects this enhanced analytical performance to translate into improved clinical performance in the studies to be carried out and reported in the coming months.
Relative to Volition's ELISA plate Nu.Q™ assay format, the magnetic particle-based assay format demonstrates:
A 10-20-fold improvement in analytical sensitivity of the assays.
Commenting on the assay transfer program Dr. Gaetan Michel, Chief Executive Officer of Belgian Volition said, "I am incredibly proud of the effort the whole team has made in the assay development program over the last two years and in particular, I would like to thank Mhammed Bougoussa, our recently appointed Assay Validation Expert for his significant contribution to the project. We now plan to finalize blood plasma sample pre-analytics with these assays and are excited to utilize these automated magnetic chemiluminescent assays in our clinical studies and aim to start reporting data during this quarter, and throughout 2020."
Volition has continued to create assets by:
Developing recombinant nucleosomes as calibrants which provide for assay specificity and reliable quantitation. Volition developed synthetic nucleosomes with its partners but has now brought this expertise in-house with the recent acquisition of Octamer, Gmbh announced January 10.
Acquisition Activity
AUSTIN, Texas, Dec. 16, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced an agreement by its subsidiary Belgian Volition SPRL to acquire an epigenetic reagent company, Octamer GmbH ("Octamer"), for approximately $725,000 consisting of cash and shares of restricted common stock of Volition. The closing of the acquisition is subject to customary conditions and is expected to occur in January 2020. This strategic acquisition helps secure the supply of one of the key components of Volition's Nu.QTM tests, the recombinant nucleosome used as the calibrant.
Commenting on the announcement Cameron Reynolds, Chief Executive Officer of Volition said, "I could not be happier that through this acquisition we will be working with one of the world's leading nucleosome experts, Dr. Adrian Schomburg. Not only will this deal secure the supply of a wide range of our key components, but it will also facilitate the transfer of know-how and expertise so that we can develop the capability to manufacture recombinant nucleosomes ourselves. This deal enhances our goal of becoming one of the world's leading epigenetics companies."
Regarding the transaction, Dr. Adrian Schomburg, Founder and CEO of Octamer said, "I believe that the progress that Volition has made to date on nucleosomes in circulation is very exciting and have confidence that this deal is a good convergence of our two technologies and companies. I look forward to working together to bring these transformative diagnostic agents into everyday diagnostic practice."
In addition to nucleosomes, Octamer manufactures and sells histones, octamers and DNA templates. These reagents can be used for custom applications in epigenetic research and drug discovery. Octamer is already revenue generating and has many business development opportunities that Volition plans to exploit in 2020 and beyond.
Hot Bio-Tech News
AUSTIN, Texas, Dec. 16, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced an agreement by its subsidiary Belgian Volition SPRL to acquire an epigenetic reagent company, Octamer GmbH ("Octamer"), for approximately $725,000 consisting of cash and shares of restricted common stock of Volition. The closing of the acquisition is subject to customary conditions and is expected to occur in January 2020. This strategic acquisition helps secure the supply of one of the key components of Volition's Nu.QTM tests, the recombinant nucleosome used as the calibrant.
Commenting on the announcement Cameron Reynolds, Chief Executive Officer of Volition said, "I could not be happier that through this acquisition we will be working with one of the world's leading nucleosome experts, Dr. Adrian Schomburg. Not only will this deal secure the supply of a wide range of our key components, but it will also facilitate the transfer of know-how and expertise so that we can develop the capability to manufacture recombinant nucleosomes ourselves. This deal enhances our goal of becoming one of the world's leading epigenetics companies."
Regarding the transaction, Dr. Adrian Schomburg, Founder and CEO of Octamer said, "I believe that the progress that Volition has made to date on nucleosomes in circulation is very exciting and have confidence that this deal is a good convergence of our two technologies and companies. I look forward to working together to bring these transformative diagnostic agents into everyday diagnostic practice."
In addition to nucleosomes, Octamer manufactures and sells histones, octamers and DNA templates. These reagents can be used for custom applications in epigenetic research and drug discovery. Octamer is already revenue generating and has many business development opportunities that Volition plans to exploit in 2020 and beyond.
Contract Awards
AUSTIN, Texas, Dec. 5, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced that it was awarded $820,000 (€740,000 Euros) and Gyros Protein Technologies AB, now part of Mesa Laboratories Inc. (NASDAQ:MLAB) was awarded $230,000 (€206,000 Euros) each in the form of a non-repayable Eurostars cash grant. The grant proceeds are to be used towards the development of novel, high sensitivity assays and a validated panel ready for regulatory trials through the combination of Volition's propriety Nu.QTM platform and Gyros Protein Technologies' Gyrolab® technology. The resulting blood-based test will be used for triaging individuals testing positive in Low Dose CT lung cancer screening.
Marielle Herzog, Research and Development Director, Belgian Volition SPRL, said "This Eurostars funding will greatly assist with the development of our groundbreaking Nu.QTM technology on a new high sensitivity platform, in addition to our current ELISA plate and bead-based assays. We are very excited to yet again broaden the range of our technology platform by working with Gyros Protein Technologies, who we believe has excellent immunoassay solutions that should complement the work we are doing."
Ivan Kamensky, Divisional Vice President of Operations and Research and Development, Gyros Protein Technologies AB, commented "Lung cancer is the leading cause of cancer death worldwide and has the lowest five-year survival rate of any cancer, with less than half of cases detected at early, treatable stages. We believe Volition's innovative biomarker panels have the potential to greatly improve the standard of care for those at high risk of lung cancer, and we are grateful to Eurostars for funding this collaborative project."
Volition and Gyros Protein Technologies will collaborate to develop 12 novel Nucleosomic™ Gyroplex™ Research Use Only ("RUO") liquid biopsy assays, based on Volition's Nu.QTM immunoassays and Gyros Protein Technologies' Gyrolab® platform, to profile unique circulating cell-free nucleosomes. Combining the latest format of both technologies, the assays will be supported by a new ultra-sensitive Gyrolab Bioaffy CD and Nu.QTM profiles to differentiate lung cancer from benign disease. A validated triage panel will be developed in a prospectively collected cohort, with the goal to be ready for regulatory trials.
Comments & Business Outlook
AUSTIN, Texas, Dec. 3, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced results from its latest proof of concept study. A single pre-clinical Nu.Q™ assay utilizing a basic microtiter plate platform detected 80% of newly diagnosed Non-Hodgkins Lymphoma ("NHL") and Leukemia cases (mixture of Acute Lymphocytic Leukemia ("ALL") and Acute Myeloid Leukemia ("AML") at 95% specificity among healthy subjects. The Area Under the Curve ("AUC") for this single assay was 91%. A number of other assays in development also demonstrated promising individual assay results with AUCs ranging from 79% to 91%.
Commenting on these results Dr. Jake Micallef, Chief Scientific Officer at Volition said, "This is a very exciting outcome as we continue the development of our assays beyond colorectal, lung and prostate cancer. We have previously announced results from both single assay and panels of Nu.Q™ biomarkers but the results of this discovery study are the best single Nu.Q™ assay result in any cancer we have demonstrated to date. We are delighted to report such promising results for Nu.Q™'s ability to detect a range of blood cancers in this small study.
The objective of this proof of concept study was to investigate a range of cancer conditions not previously studied for detection using Nu.Q™ assays and the results showed remarkable detection for all 3 blood cancers tested. The next steps are to evaluate these findings in independent larger clinical trials of symptomatic populations using Volition's automated ELISA product platform whilst we also continue pre-analytics studies".
Dr. Jason Terrell, Chief Medical Officer at Volition said, "This is an important finding for us. These types of hematopoietic malignancies are difficult to diagnose. Symptoms are often vague and non-specific such as fatigue and recurrent infections and yet the definitive diagnostic tools of bone marrow or lymph node biopsy are invasive and can be expensive. There are over 700,000 new cases of NHL, ALL and AML diagnosed globally each year and approximately 415,000 deaths. Whilst clearly more studies need to be conducted, we hope that a routine blood test using our Nu.Q™ technology could lead to earlier diagnosis."
Notable Share Transactions
AUSTIN, Texas, Oct. 29, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced the confirmation of a further $500,000 non-dilutive funding in the form of a loan from the Texas A&M SOFINEX funding agency of the Walloon Region to support the development of its subsidiary Volition Veterinary Diagnostics Development, LLC.
"We are delighted with the non-dilutive financial support we continue to receive as it allows us to develop Nu.QTM Vet products in the very exciting veterinary market. We would like to thank SOFINEX for this latest loan which takes our non-dilutive funding total from local agencies and the Walloon government to over $6 million to-date," commented Dr. Gaetan Michel, Chief Executive Officer of Belgian Volition.
The contract signing ceremony and interviews with members of the Volition and Texas A&M teams.
On Friday, October 25, Volition announced the signing of multiple agreements to collaborate with Texas A&M University ("Texas A&M"), a leading U.S. institution to develop Nu.QTM Vet products.
The signing ceremony took place at the Texas A&M campus, hosted by Dean Eleanor M. Green, DVM, DACVIM, DABVP. Also in attendance were: Dr. Heather Wilson-Robles DVM, DACVIM, Associate Professor and Dr. Fred and Vola N. Palmer Chair in Comparative Oncology, Texas A&M College of Veterinary Medicine & Biomedical Sciences, Small Animal Clinical Sciences Department; Chantal De Bleu, Director General and Phillipe La Chappelle, Director of Innovation of AWEX, the Wallonia Export-Investment Agency; members of the Volition Executive team including Chairman, Dr. Martin Faulkes and Chief Executive Officer, Cameron Reynolds.
Hot Bio-Tech News
AUSTIN, Texas, Sept. 17, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced a significant milestone in its Nu.QTM Capture development program: the ability to enrich nucleosomes, and therefore, DNA of tumor versus non-tumor origin. This breakthrough could be used in two ways, firstly to increase specificity in Volition's current assays by removing the background signal and secondly, as an enabling technology in sequencing-based liquid biopsies by enriching nucleosomes of cancer origin from the blood.
Dr. Mark Eccleston, one of the founding Scientists and the Business Development Director at Volition commented, "I am extremely excited that this enabling technology could bridge the gap between Volition's epigenetic profiling approach to early detection and those sequencing approaches that have so far been limited to personalized treatment selection. The recent results could impact the entire sector and highlight Volition as a leader in the field of Clinical epigenetics. The next step in our Nu.QTM Capture development work, which is underway and will be reported in the coming months, is to determine the level of discrimination of tumor-derived nucleosomes using mass spectrometry, immunoassay and sequencing to provide a complete analysis of cell-free nucleosomes."
Dr. Jake Micallef, Chief Scientific Officer at Volition added, "Volition is focused on advancing the science of epigenetics and has developed an extensive understanding of chromosome and nucleosome structures, particularly in blood. I believe all the work we have done over the past 9 years, including what I believe should be a breakthrough patent we filed last week with the aim of securing Nu.QTM Capture intellectual property, puts us at the cutting edge of epigenetics."
Volition is currently developing Nu.QTM products that can detect cancer by measuring circulating nucleosomes in the blood by low-cost immunoassay. In addition to these diagnostic products, Volition, through its Nu.QTM Capture platform, has developed the ability to enrich nucleosomes of cancer origin from the blood which will be valuable for wider profiling approaches such as mass spectrometry (for target discovery) and simplification of sequencing approaches, opening up the potential for its Nu.Q-Seq approach as well as partnering/licensing opportunities.
Hot Bio-Tech News
AUSTIN, Texas, Sept. 17, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced a significant milestone in its Nu.QTM Capture development program: the ability to enrich nucleosomes, and therefore, DNA of tumor versus non-tumor origin. This breakthrough could be used in two ways, firstly to increase specificity in Volition's current assays by removing the background signal and secondly, as an enabling technology in sequencing-based liquid biopsies by enriching nucleosomes of cancer origin from the blood.
Dr. Mark Eccleston, one of the founding Scientists and the Business Development Director at Volition commented, "I am extremely excited that this enabling technology could bridge the gap between Volition's epigenetic profiling approach to early detection and those sequencing approaches that have so far been limited to personalized treatment selection. The recent results could impact the entire sector and highlight Volition as a leader in the field of Clinical epigenetics. The next step in our Nu.QTM Capture development work, which is underway and will be reported in the coming months, is to determine the level of discrimination of tumor-derived nucleosomes using mass spectrometry, immunoassay and sequencing to provide a complete analysis of cell-free nucleosomes."
Dr. Jake Micallef, Chief Scientific Officer at Volition added, "Volition is focused on advancing the science of epigenetics and has developed an extensive understanding of chromosome and nucleosome structures, particularly in blood. I believe all the work we have done over the past 9 years, including what I believe should be a breakthrough patent we filed last week with the aim of securing Nu.QTM Capture intellectual property, puts us at the cutting edge of epigenetics."
Volition is currently developing Nu.QTM products that can detect cancer by measuring circulating nucleosomes in the blood by low-cost immunoassay. In addition to these diagnostic products, Volition, through its Nu.QTM Capture platform, has developed the ability to enrich nucleosomes of cancer origin from the blood which will be valuable for wider profiling approaches such as mass spectrometry (for target discovery) and simplification of sequencing approaches, opening up the potential for its Nu.Q-Seq approach as well as partnering/licensing opportunities.
Notable Share Transactions
AUSTIN, Texas, July 24, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced a further strengthening of its balance sheet with an existing investor exercising the balance of its warrant to purchase $4.8 million in aggregate amount of shares of our common stock (at $3 per share of common stock). With this exercise, the investor has fully-exercised the warrant to purchase 5 million shares of common stock that was originally issued in the private placement (PIPE) completed in August 2018.
Volition intends to use the net proceeds from this warrant exercise for continued product development, clinical studies, product commercialization, working capital, and other general corporate purposes.
Deal Flow
AUSTIN, Texas, July 10, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced that it has been awarded additional non-dilutive funding in the form of a non-repayable cash grant totaling approximately $1.4 million from the Walloon Region, Belgium. To date, Agencies from the Region have awarded Volition an aggregate of approximately $6 million in non-dilutive funding including this most recent award.
"It is a key part of our financing strategy to actively seek non-dilutive funding as this provides additional cash at favourable terms to support the Company's continued development," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "We are delighted with the great progress we are making on so many fronts and look forward to achieving many milestones throughout this year."
Dr. Gaetan Michel, Chief Executive Officer of Volition's subsidiary, Belgian Volition SPRL, commented "We are delighted with the financial assistance that we have received from the Walloon Region and would like to thank Monsieur Pierre-Yves Jeholet, the Walloon Minister for Economy for his continued support. This grant will support a specific project to be conducted in collaboration with GIGA at the University of Liege, Belgium."
Hot Bio-Tech News
AUSTIN, Texas, May 7, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced that it has added to its extensive clinical trial program with the execution of a contract under the previously announced Memorandum of Understanding, to conduct its first large-scale lung cancer study in conjunction with the prestigious National Taiwan University ("NTU"). The study will be conducted under the supervision of Professor Chen Jin-Shing in the Department of Surgery of NTU and will include 1,200 subjects receiving Low-Dose Computed Tomography scans, including 1,000 with lung cancer.
Professor Chen Jin-Shing commented: "Lung cancer remains the deadliest of all the cancers and there is a high unmet clinical need for either a non-invasive early stage lung cancer detection test or for a triage test which can improve the specificity of the Low-Dose CT scan currently used. The early data from the Nu.Q™ technology platform is promising, and clearly larger scale studies are required. We are delighted to execute this agreement and very much look forward to evaluating the Nu.Q™ technology platform".
"We are delighted with the progress we have achieved with the network of key influencers and collaborators in Asia and in particular our expanded relationship with the National Taiwan University," commented Dr. Jasmine Kway, Chief Executive Officer of Singapore Volition. "At a total cost of approximately $320,000 payable over two years, this study demonstrates once more Volition'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. We expect to release preliminary data relating to the first 600 patient samples in the first quarter of 2020."
Volition recently announced preliminary results from two proof of concept studies utilising its first optimized product-grade assay:
In a lung cancer cohort (76 subjects), a single Nu.Q™ assay detected lung cancer, including stage I lung cancer. The Area Under the Curve ("AUC") for this single assay was 85%, cancer versus healthy.
In a second confirmatory lung cancer cohort (152 subjects), the same single Nu.Q™ assay also detected lung cancer with an AUC of 79%, cancer versus healthy.
Volition has also recently executed a nonbinding Memorandum of Understanding with Shanghai Fosun Long March Medical Science Co., Ltd. with the shared intention to enter into a binding agreement and to conduct three small-scale clinical trials in China. One of the trials is in lung cancer, and the others are in colorectal cancer and ovarian cancer, with preliminary data expected in 2019.
Comments & Business Outlook
ISNES, Belgium, April 9, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") has executed a nonbinding Memorandum of Understanding ("MOU") through its wholly-owned subsidiary, Belgian Volition SPRL, with Texas A&M University, a member of The Texas A&M University System. Pursuant to the terms of the MOU, the parties will explore the feasibility of a collaborative research relationship. Any such relationship is subject to the negotiation of terms and conditions and the entry into a final binding agreement. The MOU contemplates that Belgian Volition would form a new subsidiary in the United States to focus on the veterinary diagnostic market utilizing its NucleosomicsTM technology ("Vetco") and Texas A&M University would collaborate on the research and development of veterinary diagnostic products and is interested in negotiating a shareholding in Vetco.
Dr. Heather Wilson-Robles DVM, DACVIM, Associate Professor and Dr. Fred and Vola N. Palmer Chair in Comparative Oncology, Texas A&M College of Veterinary Medicine & Biomedical Sciences, Small Animal Clinical Sciences Department commented: "The Texas A&M University College of Veterinary Medicine Oncology Department is excited for the opportunity to collaborate with Volition after some encouraging early work we have done together. Volition's innovative work in the early identification of cancer has the potential to significantly impact veterinary oncology as we know it."
Dr. Jason Terrell, Chief Executive Officer of Volition America Inc., stated: "From a commercial point of view, we are extremely excited about the possibility of offering Nu.QTM Vet tests to animal owners and veterinarians. There are currently no accurate, simple, affordable cancer screening or diagnostic tests available in veterinary medicine and yet 25% of dogs will develop cancer at some stage of their life. With pricing currently expected to be between $100-$200 per test, we believe that this is a multi-billion-dollar opportunity. We aim to have the first Nu.QTM Vet product on the market in the U.S. in 2020."
The U.S. is currently the largest veterinary market in the world with more than 55 million dogs and approximately 4.2 million cancer diagnoses each year. It has a clearly defined regulatory pathway via the USDA, requiring fewer and smaller clinical studies than the FDA process for human diagnostics which generally allows a much faster route to revenue for veterinary products as compared to human products.
Volition's recent proof of concept studies demonstrated that nucleosomes can be detected in dogs and, therefore, the potential to differentiate cancer from other conditions. The parties plan to test the Nu.QTM platform in larger trials in veterinary medicine.
"Volition's extensive intellectual property portfolio includes coverage of veterinary applications and we believe that not only could Nu.QTM Vet potentially provide significant revenue for Volition, it may also provide further technical validation of our platform in human diagnostics," commented Cameron Reynolds, Chief Executive Officer of Volition. "We are delighted to sign this MOU with Texas A&M and look forward to further developing our relationship together."
Hot Bio-Tech News
ISNES, Belgium, April 3, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced that it has added to its extensive clinical trial program with the execution of a non-binding Memorandum of Understanding, through its wholly-owned subsidiary, Belgian Volition SPRL, to conduct its first large-scale lung cancer study in conjunction with the prestigious National Taiwan University ("NTU"). The study will be conducted under the supervision of Professor Chen Jin-Shing in the Department of Surgery of NTU and will include 1,200 subjects receiving Low-Dose Computed Tomography scans, including 1,000 with lung cancer.
Professor Chen Jin-Shing commented: "The early data of the Nu.QTM technology platform is promising but clearly larger scale studies are required. Lung cancer remains the deadliest of all the cancers and there is a high unmet clinical need for either a non-invasive early stage lung cancer detection test or for a triage test which can improve the specificity of the Low-Dose CT scan currently used. I very much look forward to collaborating with Volition in evaluating its Nu.QTM technology platform".
"We are delighted with the progress we have achieved with the network of key influencers and collaborators in Asia and in particular our expanded relationship with the National Taiwan University," commented Dr. Jasmine Kway, Chief Executive Officer of Singapore Volition. "At a total cost of approximately $320,000 payable over two years, this study demonstrates once more Volition'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. We expect to release preliminary data relating to the first 600 patient samples to be reported in first quarter of 2020."
Volition recently announced preliminary results from two proof of concept studies utilising its first optimized product-grade assay:
In a lung cancer cohort (76 subjects), a single Nu.QTM assay detected lung cancer, including stage I lung cancer. The Area Under the Curve ("AUC") for this single assay was 85%, cancer versus healthy.
Comments & Business Outlook
ISNES, Belgium, March 13, 2019 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced financial results and a business update for the full fiscal year ended December 31, 2018. Volition management will host a conference call tomorrow, March 14, at 8:30a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.
Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results commented, "I could not be more proud of our dedicated team at Volition, and the ground-breaking work they are doing. During 2018, we, together with our collaborators, have made significant progress, particularly with the work on the basics of our Nu.QTM platform and its expansion into exciting new areas. I am very happy to report the initial data from the first of our product grade assays today. We aim to strengthen our product pipeline beyond colorectal cancer to cover several cancers, as well as other diseases, and to further develop our Nu.Q Capture and Nu.Q Vet products to help drive early revenue."
Mr. Reynolds added "Subsequent to the end of 2018, we further strengthened our balance sheet with existing investors exercising $6.7 million in outstanding warrants to purchase shares of our common stock and therefore start the year in a stronger position to achieve our key 2019 milestones."
Company Highlights
Financial
Cash and cash equivalents as of December 31, 2018 totaled $13.4 million compared to $10.1 million as of the end of 2017.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts. I, along with the rest of the Board and indeed the whole company, look forward to sharing the results of key studies over the coming year."
We are hosting a Capital Markets Day at the New York Stock Exchange on Tuesday April 9, 2019, with presentations from Scientific Advisory Board Member, Professor Axel Imhof of the Biomedical Center of the Ludwig-Maximilians University of Munich and from Associate Professor Heather Wilson-Robles of Texas A&M Veterinary School. We hope to provide further updates of results, ongoing projects and of plans for the potential new paths to revenues, most notably in lung cancer, Nu.Q Vet and in Nu.Q Capture.
Comments & Business Outlook
Third Quarter 2018 Financial Results
For the three months ended September 30, 2018, Volition reported a net loss of $4.48 million, or $0.14 per share. This compares to a net loss of $3.89 million, or $0.15 per share in the third quarter of 2017.
Cameron Reynolds, President and Chief Executive Officer of Volition, said, "We have had numerous highlights this quarter, with good progress being made on many fronts demonstrating the diverse nature of our platform technology. From a financial perspective I am delighted that we have strengthened the balance sheet in three ways: most importantly with completion of a private placement (PIPE) of shares of common stock and a warrant with an existing accredited investor resulting in gross proceeds of $9 million (excluding any proceeds from the exercise of the warrant); securing an additional $700,000 in non-dilutive funding from the Walloon Regional Government; and most recently, the exercise of outstanding warrants that provided approximately $717,000 in additional funds to the Company."
Mr. Reynolds commented, "The first Research Use Only kit was launched in August and we expect to add to the range of kits by the end of 2018. I am delighted to announce that these kits have been sold to several research groups and companies already, affording Volition its first potential revenue from the Nu.QTM platform. Our research and development team in Belgium are hard at work on the significant task of turning our assays into robust products that can be used worldwide. This development work will be key to our future success and is now very much bearing fruit. We are also fortunate to be working with institutions and individuals who have world-renowned reputations. We were delighted to welcome Professor Han-Mo Chiu of National Taiwan University, Principal Investigator of our Pan-Asian colorectal cancer studies, to our facility in Belgium this quarter."
Hot Bio-Tech News
ISNES, Belgium, Oct. 4, 2018 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced very encouraging preliminary results from a proof of concept study using its Nu.Q™ diagnostic test in veterinary medicine at the 10th anniversary meeting of the Belgian Technology Mission at Texas A&M University. The meeting was sponsored in part by the Wallonia Export-Investment Agency (AWEX), a long-time supporter of Volition in Belgium.
The proof of concept study demonstrated that nucleosomes can be detected in dogs and, therefore, the potential to differentiate cancer from other conditions. Volition will now test its Nu.Q™ platform in larger trials in veterinary medicine. Volition's extensive intellectual property portfolio includes coverage of veterinary medicine applications.
While the veterinary market for cancer diagnostic testing is potentially large, Volition intends to do as much of this clinical trial work as possible through external collaborations thereby maintaining its internal focus on clinical research for human diseases. Volition has engaged an experienced consultant in the United States to define the business strategy and foster key relationships necessary to launch the commercialization process.
Volition plans to determine the performance of Nu.Q™ assays in larger trials in the most prevalent forms of canine malignancies in collaboration with Dr. Heather Wilson-Robles DVM, DACVIM, Associate Professor and Dr. Fred and Vola N. Palmer Chair in Comparative Oncology, Texas A&M College of Veterinary Medicine & Biomedical Sciences, Small Animal Clinical Sciences Department.
Dr. Heather Wilson-Robles commented, "The Texas A&M University College of Veterinary Medicine Oncology Department is excited for the opportunity to collaborate with Volition. Their innovative work in the early identification of cancer has the potential to significantly impact veterinary oncology as we know it."
Dr. Jason Terrell, Chief Executive Officer of Volition America Inc., said, "We are fortunate to be a part of the unique relationship between the Wallon region of Belgium and Texas A&M University. AWEX, Texas A&M, and the various affiliates have been extraordinarily helpful and supportive of our efforts. We're confident this partnership will provide the framework to expedite the development and commercialization of our veterinary diagnostic platform. The U.S. is currently the largest veterinary market in the world and has a clearly defined regulatory pathway via the USDA, requiring fewer and smaller clinical studies than the FDA process for human diagnostics. This generally allows a much faster route to revenue for veterinary products as compared to human products."
Notable Share Transactions
ISNES, Belgium, Aug. 8, 2018 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced that it has entered into a definitive agreement with an existing accredited investor related to a private placement offering (PIPE) of 5 million shares of Volition common stock at a price of $1.80 per share, as well as a warrant to purchase up to an additional 5 million shares of Volition common stock at an exercise price of $3.00 per share payable in cash, which will result in gross proceeds to Volition before the deduction of estimated offering expenses of $9 million (excluding the proceeds from any exercise of the warrant). The warrant will have a term of one year from the closing date and be exercisable for a period of 6 months, commencing on the 6-month anniversary of the closing date. The private placement is expected to close on or about August 10, 2018, subject to customary closing conditions.
Volition intends to use the net proceeds of the private placement for continued product development, clinical studies, product commercialization, working capital, and other general corporate purposes.
Comments & Business Outlook
ISNES, Belgium, May 10, 2018 /PRNewswire / -- VolitionRx Limited (NYSE American: VNRX) ("Volition") today announced financial results and a business update for the first quarter ended March 31, 2018. Volition management will host a conference call tomorrow, May 11, at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.
Mr. Cameron Reynolds, President and Chief Executive Officer of Volition, said, "We have made great progress this quarter, moving our clinical assay development strongly forward and broadening our potential revenue base with our recently announced exclusive global license, manufacturing, sales and distribution agreement with Active Motif for a range of research use only kits." Mr. Reynolds added, "We look forward to achieving our numerous upcoming clinical and commercial milestones, while continuing to keep close control on our cash burn, which has remained relatively stable."
First Quarter 2018 and Recent Company Highlights
Signed an exclusive global license, manufacturing, sales and distribution agreement with Active Motif for a range of research use only kits.
allow researchers to explore patterns of epigenetic modifications in circulating nucleosomes across a broad range of clinical applications including cancers, inflammatory and infectious diseases; and
represent the first revenue from the Nu.QTM platform and potentially provide an additional licensing revenue stream beyond the commercialization of our blood-based cancer tests on the same platform of assays.
We made progress on a project to investigate the use of Nucleosomics® to purify or enrich nucleosomes of tumor origin. This project aims to provide purified ctDNA to help address the main technology barrier to ctDNA cancer diagnostics.
Cash and cash equivalents as of March 31, 2018 totaled $14.3 million, compared with $10.1 million as of December 31, 2017.
Upcoming Milestones
We expect to achieve the following milestones during 2018 and the early part of 2019:
Launch a range of research use only kits to be sold and distributed globally by Active Motif;
Joint Venture
ISNES, Belgium, May 9, 2018 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced that it has entered into a Global Sales and Distribution Agreement with Active Motif for a range of Research Use Only ("RUO") kits, that are based on its proprietary Nucleosomics® technology.
Founder and Chairman of Active Motif, Joseph M. Fernandez commented "We are continuously looking for innovative products in the field of epigenetics and believe Nucleosomics® is a breakthrough technology. We are delighted to announce our strategic relationship with Volition and believe their Nucleosomics® technology will complement our current range of products and should sell well. These RUO kits will provide researchers throughout the world with a new way to explore epigenetic modifications in circulating cell-free nucleosomes across different diseases from clinical samples. We aim to have the first kit available for sale by the end of June this year and are working with Volition to develop a broad range of assays focused on important targets."
The RUO kits are based on the same Nu.Q™ immunoassay technology as Volition's cancer screening panels and may be used to investigate a variety of clinical questions beyond Volition's core focus in cancer biomarkers. The range of the RUO kits will allow researchers to explore patterns of epigenetic modifications in circulating nucleosomes in disease models, pre-clinical testing and clinical trials across a broad spectrum of clinical applications including cancer, inflammatory and infectious diseases and trauma. The RUO kits will offer a complete profiling solution from cell to serum.
Chief Executive Officer of Volition, Cameron Reynolds, commented, "We are very happy to be working with Active Motif, who are key players in the field of epigenetics kits. This is a fantastic opportunity for Volition and we expect that it will provide an additional revenue stream beyond that from the expected commercialization of our blood-based tests for cancer. If the assays are developed as a companion diagnostic for another company's therapeutic, this could also potentially result in further future revenue through a licensing or similar arrangement."
Dr. Mark Eccleston, Volition's Business Development Director, commented, "Active Motif is an ideal partner for us, given its great team that has already established relationships with our target customers across the world. Not only will the sale of the RUO kits generate revenue, but such sales will also broaden potential applications of our technology and generate further validation of the Nucleosomics® platform."
Notable Share Transactions
NAMUR, Belgium, March 8, 2018 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national life sciences company focused on developing simple, easy to use, cost effective blood tests designed to help diagnose a range of cancers, announced today that it intends to offer and sell shares of its common stock in an underwritten public offering. Volition intends to grant the underwriters a 30-day option to purchase additional shares of its common stock sold in the offering, to cover overallotments, if any. All shares of common stock in the offering are being offered by Volition. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Oppenheimer & Co. Inc. is acting as the sole book-running manager for the proposed offering. National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation (NHLD), is acting as a co-manager in connection with the offering.
Volition intends to use the net proceeds of the offering for continued product development, clinical studies, product commercialization, working capital, and other general corporate purposes.
Hot Bio-Tech News
ISNES, Belgium, Feb. 26, 2018 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced interim results from its first asymptomatic colorectal cancer (CRC) frontline screening study. This ongoing study is being carried out in collaboration with Hvidovre Hospital, University of Copenhagen, Denmark and involves 680 subjects from the Danish National CRC Screening Program. The interim results demonstrated that a small panel of three ELISA assays, when considered with the subjects' ages and smoking histories, produced an area under the curve (AUC) of 83% and was able to detect 80% of Stage I CRC cases and 66% of High-Risk Adenomas (HRA) at 78% specificity, respectively.
Cameron Reynolds, Chief Executive Officer of Volition, commented, "After seven years of hard work, we are happy to announce these excellent early detection interim results from our ongoing front-line screening trial for colorectal cancer. Using only a small panel of three assays and considering certain limited patient variables, these data demonstrate that we can identify early stage and pre-cancerous adenomas at a high level of accuracy in an asymptomatic screening environment. Our tests use only a small amount of blood and could be added to routine blood screening regimens at a reasonable cost. We believe these are the first data to show high detection rates in a blood test, not only of early Stage I cancer, but also of the extremely important high-risk pre-cancerous adenomas. We believe that with further development, our Nu.QTM panel could form the basis of new CRC tests with early stage disease detection, and that our tests could become accessible to and usable by a wide section of the screening population around the world."
Hans Jorgen Nielsen, Professor of Surgical Oncology at Hvidovre Hospital in Denmark, commenting on these findings said, "These interim results are encouraging, particularly for detecting early-stage colorectal cancer and potentially pre-cancerous adenomas. Most blood-based cancer biomarkers are more effective at detection of large late-stage cancers than small early-stage cancers, and very poor at detecting pre-cancer. Certainly, these results need to be validated in larger and representative cohorts, which Volition plans to do initially in a 4,300-subject study and subsequently in a 12,000+ double blinded study, using samples collected at 10 collaborating Danish hospitals."
CRC is one of the most preventable cancers, yet it currently remains the least prevented form of cancer. The American Cancer Society Cancer Facts and Figures 2018 report provides that the five-year survival rate for CRC at all stages is 65%; however, the survival rates differ significantly depending upon the stage at diagnosis: only 14% of patients diagnosed at Stage IV survive more than five years, whereas 90% of those diagnosed at Stage I survive more than five years. This clearly underscores the importance of early detection. Moreover, while not included in the Facts and Figures report, it is widely believed that diagnosis of pre-cancer conditions like HRA and High-Grade Dysplasia can result in cancer-free survival.
In the U.S., Volition is participating in what is believed to be the largest ever CRC screening study in collaboration with the National Cancer Institute's Early Detection Research Network with a cohort of over 13,500 subjects. Collection is underway and is expected to be completed in 2020. The objective is to build upon the European studies to refine test performance and to present final data to the FDA prior to completion of the study. Volition expects to define the final panel for the U.S. front-line test within the next 18 months.
"We have now embarked with confidence on our next stage of assay development to further validate these assays, and ultimately our Nu.QTM Frontline Asymptomatic Colorectal Cancer Screening Test. This will be run in parallel with ongoing work in our 680-sample set, which still has more Nu.QTM assays to be tested," said Dr. Jake Micallef, Volition's Chief Scientific Officer. "This next stage of development is a 4,300-subject training study, which will determine the final locked down panel (which we expect to be 5-6 assays), the results of which we hope to report in the second quarter of 2018. We will then conduct a large, 12,000+ subject validation study, which we hope to begin in the second half of 2018, which will form the basis of our EU product claims. In parallel, we are progressing towards obtaining a CE Mark for this panel so that the Nu.QTM Frontline Asymptomatic Colorectal Cancer Screening Test could be available for sale in the EU later this year."
Professor Stefan Holdenrieder, Director of the Institute of Laboratory Medicine of the German Heart Center at the Technical University of Munich, Germany and a widely published expert in the field of circulating nucleosomes added, "Given these very interesting results in early cancer detection, we are very much looking forward to the upcoming results of the 27-cancer study that will follow the ongoing CRC studies. This study will analyze the performance of the Nu.Q assays in the most prevalent cancers, and it will test the depth of Nucleosomics as a platform technology beyond CRC in other major cancers."
Data is expected from this trial in 2018.
Volition will host a conference call on Tuesday, February 27 at 8:30 a.m. Eastern Time to discuss the interim results from this clinical trial as well as to provide a general business update.
Event: VolitionRx Limited Conference Call
Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call together with Louise Day, Chief Marketing & Communications Officer.
Comments & Business Outlook
ISNES, Belgium, Feb. 5, 2018 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced the successful conclusion to the Logistics and Pathway Design Study conducted by Hvidovre Hospital and The Danish Research Group. The study was established to answer the very practical, logistical questions of how a triage blood test could fit into the current Danish screening program for colorectal cancer ("CRC"). The study showed that it was indeed possible to collect, process, gather and ship the blood test from all five participating hospitals to a central laboratory within 24 hours. Furthermore, analysis from the central laboratory was shown to provide the needed data in due time (in accordance with current Danish Legislation) to decide whether or not to perform a colonoscopy.
Cameron Reynolds, Chief Executive Officer, commented "We are delighted that the team in Denmark has completed the Logistics and Pathway Design Study and positively concluded that the logistics and feasibility of using a triage concept, where the triage test is used in addition to a fecal immunochemical test to screen for CRC, seems very plausible and could indeed fit into the current Danish screening pathway. We also further welcome their conclusion that the inclusion of the triage concept could be advantageous. "
Volition has previously reported that many healthcare systems in Europe, including Denmark, are struggling to meet the increased colonoscopy demand that has come from the implementation of solely fecal-based colorectal cancer screening programs. This study demonstrates that a colorectal cancer screening triage blood test may prove beneficial in other national screening programs.
Hot Bio-Tech News
ISNES, Belgium, Jan. 3, 2018 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today released an important letter from Group CEO, Cameron Reynolds updating the company's shareholders.
In the letter, Mr. Reynolds outlines several significant accomplishments to date and highlights the fact that the company believes that it is close to achieving a key clinical milestone with the completion of a 680-subject trial for the Nu.QTM Frontline Asymptomatic Colorectal Cancer Screening Test. Volition expects to report the results from this study in early February.
"We believe that this will be our most important data release to date, given the fact that this product is for the large frontline screening market, and that it will show the accuracy of our test in a sizable cohort with a large number of assays tested" stated Mr. Reynolds.
"The study, conducted in collaboration with the Hvidovre Hospital of the University of Copenhagen, included 680 asymptomatic colorectal cancer screening subjects (including 100 cancers), and tested up to 30 assays including the largest number of Nu.Q markers tested to date, and some established orthogonal markers. From this study, a small number of markers will be taken into Volition's very large European trials this year and the company expects that this will give it a strong indication for one or more U.S. products.
This study has given us the confidence to start the next stage with a study of some 4,300 subjects, the results of which we hope to complete by March 31, 2018. We then plan to complete a large blinded 10,000+ subject study in the second quarter of 2018 to ensure that we have the data in multiple trials to back up our product claims this year. We also expect to get a CE Mark in parallel so that the Nu.Q Frontline Asymptomatic Colorectal Cancer Screening Test will be registered for sale in the 28 European Union member states by September 30, 2018. We believe that this represents a very large commercial opportunity for Volition with a total addressable market of approximately 150 million people of screen relevant age." continued Mr. Reynolds.
"We are also delighted to announce the completion of the Triage Pathway Design Study in Denmark with the report anticipated by the end of January.
Shareholder Letters
ISNES, Belgium, Jan. 3, 2018 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today released an important letter from Group CEO, Cameron Reynolds updating the company's shareholders.
In the letter, Mr. Reynolds outlines several significant accomplishments to date and highlights the fact that the company believes that it is close to achieving a key clinical milestone with the completion of a 680-subject trial for the Nu.QTM Frontline Asymptomatic Colorectal Cancer Screening Test. Volition expects to report the results from this study in early February.
"We believe that this will be our most important data release to date, given the fact that this product is for the large frontline screening market, and that it will show the accuracy of our test in a sizable cohort with a large number of assays tested" stated Mr. Reynolds.
"The study, conducted in collaboration with the Hvidovre Hospital of the University of Copenhagen, included 680 asymptomatic colorectal cancer screening subjects (including 100 cancers), and tested up to 30 assays including the largest number of Nu.Q markers tested to date, and some established orthogonal markers. From this study, a small number of markers will be taken into Volition's very large European trials this year and the company expects that this will give it a strong indication for one or more U.S. products.
This study has given us the confidence to start the next stage with a study of some 4,300 subjects, the results of which we hope to complete by March 31, 2018. We then plan to complete a large blinded 10,000+ subject study in the second quarter of 2018 to ensure that we have the data in multiple trials to back up our product claims this year. We also expect to get a CE Mark in parallel so that the Nu.Q Frontline Asymptomatic Colorectal Cancer Screening Test will be registered for sale in the 28 European Union member states by September 30, 2018. We believe that this represents a very large commercial opportunity for Volition with a total addressable market of approximately 150 million people of screen relevant age." continued Mr. Reynolds.
"We are also delighted to announce the completion of the Triage Pathway Design Study in Denmark with the report anticipated by the end of January.
Hot Bio-Tech News
ISNES, Belgium, Nov. 10, 2017 /PRNewswire / -- Singapore Volition Pte. Ltd, a wholly-owned subsidiary of VolitionRx Limited (NYSE American: VNRX) ("Volition"), has entered into a Memorandum of Understanding ("MOU") with the National Taiwan University ("NTU") to conduct two large colorectal cancer (CRC) research studies across the Asia Pacific Region, totaling approximately 7,000 patient samples. Subject to agreement on the terms and conditions, the Parties intend to sign a binding CRC Study Agreement in the first quarter of 2018.
"The signing of this MOU is a good start for Volition in the Asia Pacific Region" commented Dr. Jasmine Kway, Volition's Vice President of Asia. "We are fortunate and delighted to be working with a renowned institution and Professor Han-Mo Chiu, a prominent thought leader. This large-scale study will be low cost in line with Volition's other great value studies such as the 13,500-subject study in the U.S. and the ongoing 30,000-subject prospective study in Europe and demonstrates our commitment to conducting large trials worldwide to drive the acceptance of our products."
The first trial will be a large scale multi-country, multi-center and multi-ethnic study in the Asia Pacific Region, including 5,000 asymptomatic colorectal cancer screening subjects. The second trial will include up to 2,000 symptomatic colorectal cancer patients. These studies are being conducted to test and validate Volition's proprietary Nu.QTM platform for the detection and diagnosis of colorectal cancer for marketing, rather than for regulatory purposes.
The studies will be under the supervision of Professor Han-Mo Chiu, Clinical Professor, Department of Internal Medicine of NTU who will be the Principal Investigator for both trials. Prof. Chiu is highly regarded and widely published in this field, with many awards and achievements to his name. Professor Chiu commented, "The early detection of colorectal cancer could benefit the survival rate of patients significantly. There is a clear need for a product which not only has high accuracy but is also easy to use and affordable. I look forward to proceeding with the collaboration with Volition on these projects."
Deal Flow
ISNES, Belgium, Sept. 21, 2017 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced that it has been awarded a loan and a non-repayable grant totaling $1.5 million from SOFINEX and the Walloon Region, Belgium. This is in addition to the $947,000 in loans previously provided by Namur Invest over the last 12 months, aggregating to approximately $2.45 million.
Dr. Gaetan Michel, Chief Executive Officer of Volition's subsidiary, Belgian Volition SPRL, commented, "We are delighted with the financial support that we continue to receive from our local agencies SOFINEX and Namur Invest, as well as the Walloon Region, Belgium. We are committed to the region and plan to recruit even more of the talented scientists in the area. This funding will support our continued research and development activities towards what we hope will be life-saving cancer diagnostic tests."
David Vanston, Chief Financial Officer of Volition, commented, "It is a key part of our financing strategy to actively seek non-dilutive funding as this provides additional cash on favorable terms to support the Company's continued development."
SOFINEX, a public organization focused on the internationalization of Walloon companies and encouraging exports throughout the world, has provided an approximate $1.2 million (EUR 1 million) unsecured loan to Volition and Belgian Volition. The loan was entered into on September 20, bears interest at 4.5% per year with favorable repayment terms over seven years, and includes a two-year grace period for principal repayment. The purpose of the loan is to support the development of Belgian Volition's subsidiary, Volition America Inc., who announced in July its participation in a large 13,500 subject Colorectal Cancer Screening study in the U.S. This study is to be conducted in conjunction with the Great Lakes New England Clinical Validation Center funded by the National Cancer Institute's (NCI) Early Detection Research Network (EDRN).
Belgian Volition has also recently received a commitment from the Walloon Region, Belgium, to receive an additional non-repayable cash grant of approximately $294,000 (EUR 245,520) as a contribution towards the cost of the new custom-built research and development facility in the Crealys Science Park, Isnes, in the Walloon region of Belgium.
Namur Invest, a public-private partnership which supports the development of companies in the Walloon region, previously provided unsecured loans in October 2016 and May 2017 totaling approximately $947,000 (EUR 790,000) to Belgian Volition, bearing interest at 4-4.85% per year with favorable repayment terms over 3.5-7 years to help fund Volition's continued research and development efforts.
Hot Bio-Tech News
ISNES, Belgium, Sept. 19, 2017 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced its colorectal cancer (CRC) strategy for Europe. As part of its strategy, Volition plans to select a frontline panel to be validated in two large trials (4,300 and 10,000 sample), followed by CE marking, with a goal to launch a European frontline CRC screening product in 2018.
Chief Executive Officer of Volition, Cameron Reynolds, commented, "We believe that the market for the frontline screening test represents the largest near-term opportunity for Volition, as there are 150 million Europeans of screening age. Our strategy for Europe is now in place using patient samples that have already been secured in our very large ongoing Danish trials. Our U.S. strategy includes a 13,500-patient study in collaboration with the Early Detection Research Network (EDRN) of the U.S. National Cancer Institute (NCI). We have also made significant progress in Asia. We look forward to executing on our worldwide strategies and to the anticipated launch of our frontline test in Europe in 2018."
"We are making significant progress with our frontline CRC screening test," said Dr. Gaetan Michel, Chief Executive Officer of Belgian Volition. Dr. Michel added, "We have received considerable support from the local government and agencies which has helped Volition's operations, notably through the large increase in capacity from our purpose-built facility which allows us to conduct more clinical trials effectively. This has also helped us grow our talented team and make key hires, which we will continue to do."
The current 12-month plan:
Fourth Quarter, 2017 - Volition aims to complete its choice of a panel for the Nu.QTM colorectal cancer screening test for Europe.
Comments & Business Outlook
ISNES, Belgium, Sept. 14, 2017 /PRNewswire / -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") today announced that it has been granted four additional patents relating to its proprietary Nu.QTM platform. The newly-issued patents further strengthen Volition's intellectual property portfolio worldwide.
Dr. Jake Micallef, Chief Scientific Officer of Volition, commented, "Our worldwide portfolio of granted patents that protects various aspects of Volition's Nu.QTM technology is growing. These most recent patents further solidify our market position in blood tests for circulating chromosome fragments from dead cancer cells and we continue to apply for additional patents in this area."
Cameron Reynolds, Chief Executive Officer of Volition, added, "The granting of these patents is excellent news. It reconfirms the novelty of Volition's technology and will further protect Volition commercially as we progress towards commercialization of the platform."
The granted patents include:
US 9,709,569, Method for Detecting Nucleosome Adducts - granted in the U.S. on July 18, 2017
Comments & Business Outlook
Second Quarter 2017 Financial Results
For the three months ended June 30, 2017, Volition reported a net loss of $3.5 million, or $0.13 per share. This compares to a net loss of $2.90 million, or $0.13 per share in the second quarter of 2016.
Cameron Reynolds, President and Chief Executive Officer of Volition, said, "We have had numerous highlights this quarter, with strong progress being made on many fronts. I am delighted with the growing strength of new talent in our team, especially the growth in our Research and Development Team in Belgium. We are also fortunate to be working with institutions and individuals who have brilliant reputations." Mr. Reynolds continued, "We continue to announce large trials, such as the recent signing of a 13,500 patient U.S. trial in colorectal cancer. We believe that this most recently announced trial, with a cost to us of only $3 million, represents an exceptional value for our money. We look forward to achieving additional milestones in the upcoming quarters and sharing further exciting news."
Hot Bio-Tech News
AUSTIN, Texas, July 18, 2017 /PRNewswire / -- Volition America, Inc. (Volition America), a wholly-owned subsidiary of VolitionRx Limited (Volition; NYSE MKT: VNRX), has signed an agreement to participate in a large multi-center clinical study with the Great Lakes New England Clinical Validation Center funded by the U.S. National Cancer Institute's (NCI) Early Detection Research Network (EDRN).
The clinical study will provide approximately 13,500 asymptomatic screening samples of people aged 50 or over who have not previously undergone screening or a diagnostic colonoscopy. Already 4,677 samples have been collected and up to 9,000 will be prospectively collected. The aim of the trial will be to validate a panel of biomarkers that include Volition's Nu.Q™ Colorectal Cancer Screening Test in a large asymptomatic population to support U.S. regulatory approval. The study sample collection is expected to take 2 to 3 years. Volition America will contribute up to $3 million towards this public-private arrangement paid in instalments over a 3-year period.
Volition's Chief Executive Officer, Cameron Reynolds, commented, "This is exciting news for Volition and very much advances our efforts in the U.S. market. We believe this large scale clinical study will be invaluable when we seek FDA approval for Nu.Q™. The public-private arrangement involves joint governmental and private funding and reduces our costs to $3 million, and we believe that it represents exceptional value for money. We are delighted to work with U.S. institutions and the United States National Cancer Institute with such outstanding reputations who share our aims in improving early diagnosis of cancer."
The NCI is the leading cancer research organization in the U.S. with 69 NCI-Designated Cancer Centers that are at the forefront in supporting cancer research across the U.S. The EDRN is an initiative of the NCI which is focused on early cancer detection. It is the force behind inter-governmental, inter-institutional and public-private collaboration building for the rapid advancement of biomarkers and early detection science.
Dr. Jason Terrell, Chief Medical Officer of Volition and the Chief Executive Officer of Volition America, commented, ''We are extremely excited about joining this study and are confident that our relationship with the EDRN will be highly beneficial to both parties. This study is a major milestone for Volition and will provide significant clinical data for us as we move firmly into the U.S. market and commence the process of launching a frontline screening test in the U.S."
Hot Bio-Tech News
ISNES, Belgium, June 27, 2017 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today has issued corrections to certain statements made in the press release issued by the Company on May 9, 2017 regarding the Company's Nu.Q™ Colorectal Cancer Screening Triage Test. Due to the Company's administrative error, Professor Hans Jorgen Nielsen from Hvidovre Hospital, University of Copenhagen, did not have adequate opportunity to review and comment upon the release or approve his included statement prior to its publication. The Company apologizes unreservedly for this oversight and has significantly revised its data review and reporting policy to prevent similar occurrences in the future.
Triage update: in the May 9th press release, we announced results showing that 24.5% of colonoscopies could be avoided and almost 95% of colorectal cancers and 87.9% of high-risk adenomas detected. While those topline numbers are accurate, further detailed analysis carried out during the last month has shown the selected immunoassays individually had a high p-value and therefore are in the process of being replaced. This continuing analytical process is part of an ongoing evaluation of results of lab work, to discover and select the most effective immunoassays, with the aim of achieving the highest possible results.
The Company looks forward to publishing further detailed analysis of this data, as well as results from the ongoing Triage Pathway Design Study over the coming months.
Hot Bio-Tech News
NAMUR, Belgium, May 18, 2017 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today announced the publication of a research paper entitled "Circulating nucleosomes as new blood-based biomarkers for detection of colorectal cancer". The study was published in Clinical Epigenetics in collaboration with the CHU UCL Namur, Site de Mont Godinne, Belgium.
Volition's Chief Executive Officer, Cameron Reynolds, commented, "I am delighted that this paper reporting one of our earlier pilot studies has been accepted for peer review publication. To detect colorectal cancer and pre-cancerous polyps with such high accuracy is extremely encouraging, particularly the high early-stage detection. We are focused on using these exciting results to develop our frontline product. Our product development process involves large trials of thousands of patients and extensive assay development work at our new purpose-built facility in Belgium."
The lead author of the paper, Professor Jean-François Rahier, is a gastroenterologist and a recognized member of the Belgian research group on inflammatory diseases BIRD (Belgian IBD Research group) and the European group ECCO (European Crohn and Colitis Organization). Professor Rahier commented, "The development of better methods for the early detection of colorectal cancer is critical for the improvement of patients' survival rates. We have found that a Nu.Q™ panel test detects colorectal cancer and pre-cancer with high accuracy, indicating it may prove to be useful as a routine clinical colorectal cancer blood test."
Our four Nu.Q™ assays demonstrated Colorectal Cancer (CRC) detection accuracy of 74% sensitivity at 90% specificity and detected all stages of the cancer, including 75% of early stage I cancers. The study also showed that by using an age adjusted scoring system the accuracy of CRC detection increased to 91% of cancers at 90% specificity. The study consisted of 58 patients over 50 years of age classified into three groups based on their colonoscopy reports: (i) patients with CRC (n = 23), (ii) patients with polyps (n = 16), and (iii) healthy controls with no endoscopic lesions (n = 19).
The results in early stage cancers showed to be particularly positive in comparison to the current, most commonly used blood test for colorectal cancer, Carcinoembryonic Antigen (CEA). In this study, in comparison to the Nu.Q™ results, the CEA results gave a detection rate of 35% of cancers overall at 90% specificity; however, critically, CEA detected no stage I cancers. Not only did the study show very good early stage detection with Nu.Q™ assays, it also demonstrated high pre-cancer polyp detection, with a different Nu.Q™ panel of four assays detecting 62% of polyps at 90% specificity. These are both extremely encouraging outcomes of the study.
Comments & Business Outlook
First Quarter 2017 Financial Results
For the three months ended March 31, 2017, Volition reported a net loss of $3.35 million, or $0.13 per share. This compares to a net loss of $2.49 million, or $0.13 per share for the quarter ended March 31, 2016.
Cameron Reynolds, President and Chief Executive Officer of Volition, said, "I am delighted with the progress we are making on many fronts. As I have always said, our team is extremely important to us and we continue to grow stronger." Mr. Reynolds continued, "We have kept very close controls of costs despite the high level of research and development and marketing activity in a broad range of areas, and yet again we have completed many milestones on a relatively tight budget to ensure we use our shareholders' equity carefully. 2017 is off to a strong start and I am proud of the team's accomplishments in the first quarter. We look forward to achieving additional milestones in the second quarter as we ramp up into a commercial stage company in 2017."
Hot Bio-Tech News
NAMUR, Belgium, May 9, 2017 /PRNewswire / -- At the Digestive Disease Week 2017 (DDW) in Chicago, VolitionRx Limited (NYSE MKT: VNRX) presented results that continue to show that the Nu.QTM Colorectal Cancer Screening Triage Test reduces the total number of colonoscopy referrals while maintaining high sensitivity for cancer detection.
"We have successfully completed this key clinical milestone in the launch of our Nu.QTM Triage product. This study, with the total cohort totalling just under 8000 subjects demonstrates that the Nu.QTM Triage test was able to prevent 24.5% of colonoscopies and detect almost 95% of colorectal cancers and 87.9% of high-risk adenomas. It further strengthens the case for the Nu.QTM Colorectal Cancer Screening Triage test to be incorporated into colorectal cancer screening programs," said Louise Day, Chief Marketing and Communications Officer at Volition.
Professor Hans Jorgen Nielsen from Hvidovre Hospital, University of Copenhagen, commented, "These results, from a very large data set, confirm that the Nu.QTM Triage test has the potential to accelerate the diagnosis of colorectal cancer, by reducing the number of unnecessary colonoscopies being performed thereby allowing more people to be screened quickly and effectively."
CFO Trail
NAMUR, Belgium, April 11, 2017 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), is delighted to announce that David Vanston (FCCA, MBA) joined Volition as its new Chief Financial Officer, effective 10th April 2017. Mr. Vanston joins Volition from Octo Telematics, a high-growth technology company based in Boston, where he was the Senior Controller for the U.S. business. Mr. Vanston will be responsible for leading Volition's finances and will play a key role in Volition's increased global activity. Mr. Vanston succeeds David Kratochvil who tendered his resignation in November 2016, but kindly agreed to continue in the role during his notice period until his successor was found.
Mr Vanston brings with him a strong background as an international finance executive and a senior controller, including extensive experience in Sarbanes-Oxley compliance and implementation of successful change programs. He has worked in a variety of sectors from manufacturing and technology to life sciences, with globally-listed companies whose revenues range from $20 million to $700 million.
Volition's Chief Executive Officer Cameron Reynolds commented: "I am delighted that David is joining Volition. I am confident that given his background and experience, David will add value as we become a revenue-generating company." Mr. Reynolds added, "We would also like to thank Mr. Kratochvil for his contributions to Volition during his tenure with us and we wish him well in his future endeavours."
Mr. Vanston has 20 years of financial management experience. Prior to Volition and Octo Telematics, Mr. Vanston held positions as Vice President of Excorp Medical, Inc., an early-stage company, Chief Financial Officer for GrowHow Ltd and Vice President Europe, Finance for Monster Worldwide, Inc. Mr Vanston managed and oversaw the accounting, finance, tax, treasury, financial planning and analysis of the business.
Mr Vanston is a certified chartered accountant and holds an MBA from Warwick Business School.
Hot Bio-Tech News
NAMUR, Belgium, March 2, 2017 /PRNewswire / -- Volition (NYSE MKT: VNRX) announced today that it has begun a two-phase logistical study of the Company's novel Nu.QTM Colorectal Cancer Screening Triage blood test. The study is in collaboration with Hvidovre Hospital and The Danish Research Group on Early Detection of Colorectal Cancer; both phases are expected to be completed within 6 months.
The first phase of the study starts today in the Capital Region of Denmark and involves three centres and up to 250 subjects. The aim of the study is to evaluate the logistics in collecting and processing blood samples at a local screening centre and subsequently shipping the samples to a central laboratory in Denmark to run the Nu.QTM analysis. This phase is expected to be completed within 2 months.
The second phase of the study is due to start after Ethical Approval and will involve five centres and up to 500 subjects. Specifically, this phase will assess the time taken between blood collection, analysis and results. When added to the existing clinical data previously announced, this logistics study aims to complete the information needed to add our test to the national screening program.
Morten Rasmussen MD. Ph.D., head of the colorectal screening program in the Capital Region of Denmark, commented "We have been impressed with the preliminary clinical data of the Nu.QTM Colorectal Cancer Screening Triage Test and the potential to reduce unnecessary colonoscopies. Many healthcare systems in Europe, including Denmark, are struggling to meet the increased colonoscopy demand that has come from the implementation of fecal-based colorectal cancer screening programs. Before introducing any such test into the Danish National Screening program, we need to determine the very practical logistics of putting into practice Volition's Nu.QTM Triage Test to ensure a smooth, patient-friendly, and efficient implementation of our screening programme."
Volition's CEO Cameron Reynolds added: "This is extremely important news for Volition in the implementation of our commercialisation strategy for our first product. Denmark has one of the most advanced healthcare systems in the world and is viewed by many as strong innovators. We have had a long, mutually beneficial relationship with our collaborators in Denmark and are very pleased that this logistics study will be undertaken to answer key issues to make sure any potential roll out nationally would be smooth. We also envisage this study will assist other countries in assessing the implementation of the Nu.QTM Triage Test within their National Screening Programs."
Hot Bio-Tech News
NAMUR, Belgium, Feb. 24, 2017 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) has presented data at the World Congress of GI Endoscopy (ENDO) 2017 conference in Hyderabad, India, from a study that confirms prior test results that the Nu.QTM Colorectal Cancer Screening Triage test reduces the total number of colonoscopy referrals while maintaining high sensitivity for cancer detection.
"This is a key clinical milestone in the launch of our Nu.QTM Triage product. This validation study, in a second population of 1,961 subjects, greatly assists us with sales and marketing efforts in the EU and Asia," said Louise Day, Chief Marketing and Communications Officer at Volition.
The lead author of the study, Dr. Marielle Herzog, commented, "This data confirms the role that the Nu.QTM Triage test can play in accelerating the diagnosis of colorectal cancer."
Comments & Business Outlook
NAMUR, Belgium, Jan. 5, 2017 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today announced that the Company is expanding into the Asian markets with the appointment of Dr. Jasmine Kway as Vice President of Asia. This geographic expansion follows on from Volition's recent announcement that the Company's first blood-based diagnostic cancer test, the Nu.QTM Colorectal Cancer Triage Test, has achieved a CE mark, allowing for its sale in all 28 EU countries. Volition plans to bring the product to market in Europe this year and will be working with Dr. Kway to expand into the Asian markets with direct marketing to countries with screening programs as well as seeking the required approvals for use in the new Asian markets.
Dr. Kway has a proven track record in achieving positive business results by developing strategic business alliances, identifying new markets, and developing business processes. To date she has worked with numerous health and regulatory bodies across Asia and has successfully introduced numerous private sector companies into the Asian markets.
In addition to her considerable business experience, Dr. Kway is widely acknowledged as one of the world's leading intellectual property (IP) strategists, having been included in Intellectual Asset Management's (IAM) IAM Strategy 300 – The World's Leading IP Strategists for the past four consecutive years. She is a key thought leader in the technology management and technology transfer industry, and is frequently called upon by the World Intellectual Property Office (WIPO) to provide technology transfer and IP training worldwide.
Volition's CEO, Cameron Reynolds, commented, "Jasmine's depth of experience in driving corporate IP strategies and business development, as well as bringing products to market in Asia, will be a huge asset to Volition going forward, and we are delighted that she has agreed to join the Volition team."
Prior to joining Volition, Dr. Kway served as Chief Executive Officer of IP practice at RHT i-Assets Advisory, one of the leading companies of the RHT Group of Companies and RHT Holdings (RHT), a Singapore headquartered integrated leading professional services company providing professional services in Asia. While at RHT i-Assets Advisory she was focused on managing buy side and sell side clients globally in technology/IP transactions, business development, and fund raising.
Prior to RHT i-Assets Advisory, Dr. Kway worked in both the private and public sectors, including as Executive Vice President, Business Development at Transpacific IP Group Limited from 2010 to 2015, and as Director of Industry Liaison of the National University of Singapore from 2005 to 2010. In these positions, Dr. Kway formulated and implemented national IP policies, corporate IP strategies and management, IP and technology development, commercialization, fundraising, and investment.
Volition currently holds a number of patents for its proprietary Nucleosomics® technology, a platform technology that measures and identifies signatures of nucleosomes circulating in the blood. All Volition's diagnostic tests for cancer use its core Nucleosomics® technology. The Company achieved a CE mark for its first diagnostic test, the Nu.QTM Colorectal Cancer Screening Triage Test, in December of 2016 and has begun marketing this in Europe.
Comments & Business Outlook
Third Quarter 2016 Financial Results
For the three months ended September 30, 2016, Volition reported a net loss of $3.48 million, or $0.15 per share. This compares to a net loss of $2.96 million, or $0.16 per share in the third quarter of 2015.
Cameron Reynolds, President and Chief Executive Officer of Volition, said, "I am extremely pleased with the team's efforts over the past several months. We continue to bolster our capabilities with the appointment of a new COO in our subsidiary in Belgium and the acquisition of our new 19,000 square foot facility, as well as strengthening our cash position. With respect to the excellent data produced by our Nu.Q™ Colorectal Cancer Screening Triage Test, the Company expects to make further announcements regarding CE marking, commercial launch and implementation of this test in specific geographies during the next 3-6 months."
Jake Micallef, Ph.D., MBA, Chief Scientific Officer of Volition, commented, "This quarter, we are proud to announce the results of our Nu.Q™ Colorectal Cancer Screening Triage blood test, which we expect to CE mark later this year and hope to launch in Europe in early 2017, making it potentially saleable in all 28 EU countries. This is a unique product designed to address a specific market need. Less than 10% of people with a positive FIT score have colorectal cancer; a positive FIT score is not a diagnostic for cancer but means simply that blood has been found in the stool. This means that there are a significant number of unnecessary expensive and invasive colonoscopies performed, placing a burden on both the patient and healthcare system. Studies have demonstrated that the combination of FIT test and our Nu.QTM Colorectal Cancer Screening Triage blood test identified nearly 97% of colorectal cancers in FIT positive subjects. By utilizing this regimen, screening programs could reduce the number of unnecessary colonoscopies and relieve pressure on healthcare resources. Given the medical and market need, we believe that Volition is primed to offer its triage blood test to potentially thousands of FIT positive patients diagnosed in Europe each year."
Volition has also partnered with Hvidovre Hospital in Denmark for a new large world class 30,000 patient (and 90,000 sample) trial. This patient sample collection is an investment for the future which Volition believes will be central to its product development in colorectal cancer and other cancer diseases into the next decade.
Hot Bio-Tech News
NAMUR, Belgium, Nov. 3, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing diagnostic tests for cancer, today announced its collaboration with Hvidovre Hospital, University of Copenhagen, Denmark in a prospective clinical study of 30,000 patients. This ambitious clinical study signifies Volition's commitment to the discovery of new cancer blood tests into the middle of the next decade. Pursuant to the terms of the collaboration, Volition has agreed to make payments of 7.5 million Danish Krone (approximately $1.1 million USD) per year for the first two years of the study (Phase I). After the completion of Phase I, Volition may elect to continue with Phase 2 and/or Phase 3 of the study upon payment of 7.5 million Danish Krone annually for up to an additional 4 years.
Under the terms of the study, a total of 90,000 blood samples will be collected from 30,000 patients who have tested negative in a national fecal colorectal cancer screening test. A blood sample will be collected from each patient on three separate occasions at 2-year intervals, and the study will follow his or her progress over time. Volition will test whether, and how early, its Nu.QTM assays detect cancer in samples taken before the definitive diagnosis of colorectal cancer. All blood samples will be accompanied by up to 120 clinical information data points, including life style factors and a wide range of other diseases, allowing Volition to use this study in a wider context for other cancers.
Professor Hans Jorgen Nielsen from Hvidovre Hospital, University of Copenhagen, voiced his support for the study, saying: "We are very pleased to be continuing our work with Volition, especially on a study that is identifying patients who are going undiagnosed under the current screening system. This is an incredibly powerful longitudinal study because we are going to be collecting a huge amount of data over a seven-year period."
Jake Micallef, PhD, Chief Scientific Officer at Volition said, "We are delighted to be working with the Hvidovre Hospital again. We believe that this is one of the biggest clinical studies ever undertaken. Each sample collected will be sufficient for multiple Nu.QTM tests and the study will form the basis for our product pipeline in multiple cancers for many years to come."
Dr. Jason Terrell, Volition's Chief Medical Officer and Head of U.S. Operations, commented: "The study with Hvidovre Hospital can play a major role in the expansion of our clinical development program. Large prospective studies of this quality provide invaluable clinical information. The partnership with Hvidovre Hospital will support our mission to deliver accurate and cost-effective early stage cancer diagnostics."
Volition and Hvidovre Hospital expect to have initial interim results from this study by the end of 2018. Volition currently has numerous other ongoing studies on its Nu.QTM blood tests, and its first test, the Nu.QTM colorectal cancer triage test, is expected to have a commercial release in early 2017.
Comments & Business Outlook
NAMUR, Belgium, Oct. 26, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), today announced its acquisition of a new research and development facility located in the Crealys Science Park, Les Isnes in the Wallonia region of Belgium, an area popular with other leading biotech and pharmaceutical companies.
Belgian Volition expects to move into its new facility in March 2017. The move will give the Company the capacity to carry out clinical trials with additional Tecan machines and to expand its scientific team. The new custom-designed facility is divided into 9,000 square feet of officespace, and 10,000 square feet of tailor-made laboratory space. Currently, Belgian Volition occupies an approximate 4,000 square foot space.
Belgian Volition acquired the property for EUR 1.2 million, of which EUR 1.12 million was financed pursuant to a Real Estate Capital Lease Agreement with ING Asset Finance Belgium S.A. As part of the transaction, Belgian Volition granted ING a right of emphyteusis (a form of leasehold) on the property and ING granted Belgian Volition a 15-year lease over the property with an option for Belgian Volition to purchase the property outright at the end of the lease upon payment of EUR 33,600. The investment was also supported with the financial backing of Preface S.A./Namur Invest.
"We are looking forward to moving into our new R&D facility as we are exceeding maximum capacity at our current facilities. We believe that this exciting upgrade will allow us to accelerate our clinical trials and expedite the commercialization of our products" said Dr. Gaetan Michel, CEO of Belgian Volition, "I would like to thank Preface S.A./Namur Invest for all of their support to help make this option very affordable for a company our size."
The Company also announced that, effective November 2, 2016, Dr. Philippe Willemsen (PhD, MSc and BSc) has been appointed as Chief Operating Officer for its wholly-owned subsidiary, Belgian Volition SPRL. Dr. Willemsen brings with him eleven years of experience in the biopharmaceutical environment and cell therapy manufacturing. He joins Belgian Volition from Promethera Biosciences, where he has served as Senior Pilot Plant Manager since 2011. Dr. Willemsen received his PhD from the University of Liege, Belgium, where he also received his BSc and MSc. Dr. Willemsen specializes in molecular, cellular biology, and stem cells.
"We are delighted to welcome Philippe to the Belgian Volition team," said Dr. Michel. "He brings with him a wealth of experience and joins us at an exciting time as we prepare to launch our first Nu.QTM test. His appointment to manage operations in Belgium will allow me to focus on my role as global product manager for the Nu.QTM Colorectal Cancer Screening Triage Test (blood test), for which we expect to receive CE marking later this year. "
Notable Share Transactions
NAMUR, Belgium, Oct. 21, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing diagnostic tests for cancer, today announced that the Underwriter of its previously announced underwritten public offering of 2.25 million shares of common stock has exercised its option to purchase an additional 234,404 shares at $5.00 per share to cover over allotments, bringing the total gross proceeds from the offering to approximately $12.4 million. The net proceeds are expected to be approximately $11.7 million, after deducting underwriting discounts, commissions and estimated offering expenses payable by Volition. All of the shares in the offering and the over-allotment were offered by Volition. The exercise of the over-allotment option closed on October 21, 2016.
National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation (NASDAQ: NHLD), acted as sole book-running manager for the offering. Lake Street Capital Markets and The Benchmark Company, LLC acted as advisors in the offering.
Volition intends to use the net proceeds of the offering for continued product development, clinical studies, product commercialization, working capital, and for other general corporate purposes.
Notable Share Transactions
NAMUR, Belgium, Sept. 29, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing diagnostic tests for cancer, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Volition intends to grant the underwriters a 30-day option to purchase an additional 15% of the shares of common stock sold in the offering, to cover over-allotments, if any. All shares of common stock in the offering are being offered by Volition. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation (NHLD), is acting as sole book-running manager for the offering. Lake Street Capital Markets and The Benchmark Company, LLC have acted as advisors in the Offering.
Volition intends to use the net proceeds of the offering for continued product development, clinical studies, product commercialization, working capital, and for other general corporate purposes.
The securities described above are being offered by Volition pursuant to a "shelf" registration statement on Form S-3 (File No. 333-206781), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (SEC) on September 18, 2015. A preliminary prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC's website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained from National Securities Corporation, Attention: Kim Addarich, 410 Park Avenue, 14th Floor, New York, NY 10022, or by telephone at (212) 417-8164, or by e-mail at prospectusrequest@nationalsecurities.com.
A final prospectus supplement describing the terms of the offering will be filed with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Comments & Business Outlook
Second Quarter 2016 Financial Results
For the three months ended June 30, 2016 , VolitionRx reported a net loss of $2.9 million , or $0.13 per share. This compares to a net loss of $1.9 million , or $0.10 per share in the second quarter of 2015.
Cameron Reynolds , President and Chief Executive Officer of VolitionRx, said, "CE marking another two of our biomarker assays, NuQ�V001 and NuQ�T003, which brings the total to three CE marks, helps clear the regulatory path for transition into a commercial-stage company. With the expected launch of our first NuQ� blood test later this year in Europe , our efforts over this and the upcoming quarter are focused not only on meeting these regulatory hurdles, but also making the key management appointments to ensure a successful launch."
"With respect to our first commercial product launch, the Company expects to be making announcements during September and October to discuss this in greater detail, including the specific role it will play in the screening regimen for specific countries and our market entry strategy. We have already begun our branding and labeling processes for our initial commercial product and have engaged a branding agency to assist us with the launch. We aim to have this product CE marked by the end of this year, making it potentially saleable in 2017 in all 28 EU countries."
Jake Micallef , Ph.D., MBA, Chief Scientific Officer of VolitionRx, said, "We have had several important clinical accomplishments for NuQ� in this second quarter of 2016. The publication of our study in the Scandinavian Journal of Clinical and Laboratory Investigation confirms that results of our NuQ� test are the same regardless of when and how blood samples are taken due to the discovered stability of circulating cfnucleosomes, a key highlight of the viability and ease-of-use of our platform. At the World Endoscopy Organization (WEO) Colorectal Cancer Screening Meeting, Jason Terrell , M.D., Volition's Chief Medical Officer and Head of U.S. Operations, presented data from our targeted clinical trial of 430 pre-cancerous colorectal adenoma patients with Hvidovre Hospital and the University of Copenhagen that demonstrated a panel of five NuQ� biomarker assays in an age-adjusted algorithm detected 75% of high-risk colorectal adenomas and 86% of stage I colorectal cancers. These are our highest adenoma detection rates yet, and they demonstrate the power of NuQ�, not only for the detection colorectal cancer, but also for pre-cancerous polyps."
Hot Bio-Tech News
NAMUR, Belgium, July 27, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing diagnostic tests for cancer and other conditions, today announced that the U.S. Patent and Trademark Office granted the Company U.S. Patent Number 9,400,276 titled "Method For Detecting Nucleosomes Containing Histone Variants."
The new U.S. patent, issued on July 26, 2016 and expiring on August 31, 2032, relates to VolitionRx's Nucleosomics® platform for the detection of fragments of chromosomes, called nucleosomes, circulating in the blood. This patent is complementary to and will support the first three patents granted to VolitionRx in the U.S.
Dr. Jake Micallef, Chief Scientific Officer of VolitionRx, remarked, "Volition now has been granted four U.S. patents covering three of the four core epigenetic areas of our Nucleosomics® technology, including nucleosomes containing histone modifications, histone variants and nucleosome adducts as well as methods for detecting nucleosomes per se. Additional patent applications covering the measurement of nucleosomes containing DNA modifications are pending."
Cameron Reynolds, Chief Executive Officer of VolitionRx, added, "We are very pleased with this U.S. patent grant, our fourth in total. Our proprietary Nucleosomics® approach, which detects mutations present throughout the entire nucleosome, differs from the more common approach of analyzing only the DNA strand. This important patent adds to our intellectual property portfolio and further strengthens our ability to protect commercially our groundbreaking work in this cutting edge field."
Results from clinical trials to date demonstrating the effectiveness of VolitionRx's NuQ® biomarker assays include:
Colorectal cancer and pre-cancerous colorectal adenomas
Interim results from a 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark), released September 9, 2015: Panel of four NuQ® biomarker assays detected 81% of colorectal cancers at 78% specificity and 67% of high-risk adenomas. For more information click here.
Results from a 59-patient retrospective study (Lund University, Sweden) published in Clinical Epigenetics online journal (http://www.clinicalepigeneticsjournal.com/content/pdf/s13148-015-0139-4.pdf), October 7, 2015: Panel of four NuQ® biomarker assays plus CA 19-9 classical biomarker detected 92% of pancreatic cancers at 100% specificity. For more information click here.
Results from a 537-patient retrospective study (Surrey Cancer Research Institute at University of Surrey, United Kingdom), released April 20, 2016 at the AACR Annual Meeting: A single NuQ® biomarker assay detected 71% of early stage I prostate cancer cases and 86% of late stage IV prostate cancer at 93% specificity, which is significantly higher than the commonly-used PSA test reported to detect 53% of prostate cancers at 73% specificity. For more information click here.
Interim results (73 of 240 patients collected and assessed) from a prospective study (Liege University Hospital, Belgium), released November 19, 2015: Panel of four NuQ® biomarker assays detected 93% of lung cancers at 91% specificity and differentiated lung cancer from the common lung disease, COPD. For more information click here.
Hot Bio-Tech News
NAMUR, Belgium, Feb. 17, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today announced results demonstrating that the Company's NuQ® blood test accurately detected 75% of colorectal adenomas, or pre-cancerous polyps, that were most likely to become cancerous. A panel of five of NuQ® biomarker assays also detected 86% of early (stage I) colorectal cancers. The completed clinical trial of 430 patients was conducted with the Hvidovre Hospital and with the University of Copenhagen in Denmark.
The study was specifically designed to assess the effectiveness of VolitionRx's NuQ® blood-based biomarker assays in detecting adenomas before they become cancerous, as well as early stage colorectal cancer. If adenomas are caught early enough and removed, the risk of subsequent cancer is significantly reduced.
The 430 patients, who either presented with symptoms suggesting the presence of colorectal cancer or were high-risk subjects, included 42 subjects with stage I cancer, 46 subjects with stage II cancer and 181 subjects with colorectal adenomas. No later stage cancers were included in the study. The trial was double blinded and age-adjusted; the results were at 78% specificity.
VolitionRx's proprietary NuQ® blood tests are based on biomarker assays that can identify fragments of chromosomes, called nucleosomes, circulating in the blood and analyze them for epigenetic modifications that signal that cancer is present. The final NuQ® test will likely consist of a panel of 4-6 individual biomarker assays that require only a single drop of blood from patients. During this trial, VolitionRx tested a number of new biomarker assays in order to refine the make-up of the panel and produce the highest accuracy detection rates.
Colorectal cancer is one of the most preventable cancers, yet there are still 50,000 deaths and more than 130,000 new cases diagnosed every year in the U.S. alone.1 Colonoscopy examinations provide a high percentage of detection, yet due to their invasive and costly nature, more than one third of adults of screening age in the U.S. are not screened with such a procedure.2 The five-year survival rate for colorectal cancer is 90% when detected at stage I but only 13% if detected at stage IV.
Professor Hans Jorgen Nielsen, Professor of Surgical Oncology at Hvidovre Hospital in Denmark, said, "This study shows extremely good detection of dangerous pre-cancer and early-stage cancer with the non-invasive NuQ® blood test. We are now working with VolitionRx on large retrospective and prospective trials in both screening and symptomatic populations. We expect to release more data from both these studies later this year."
VolitionRx's Chief Scientific Officer, Dr Jake Micallef, said, "Current blood tests and commonly used fecal tests are poor at detecting early stage colorectal cancer or pre-cancer, so we are very excited by these results. NuQ® tests are detecting early stage colorectal cancer and even pre-cancerous polyps that can be removed before cancer can develop. Finding tumors before they spread is a crucial breakthrough that has the potential to significantly improve the outcomes for colorectal cancer patients. In recent months, VolitionRx has identified and manufactured a number of new biomarker assays and now has a greater pool of NuQ® biomarker assay candidates from which to select the panel for the final blood test. These results demonstrate the increased accuracy from this optimization. We are now running these new biomarker assays in all our colorectal cancer trials."
Cameron Reynolds, Chief Executive Officer of VolitionRx, commented, "Not only do these results demonstrate our best detection rates to date for colorectal adenomas, but they further confirm the progress that VolitionRx is making in identifying new NuQ® biomarker assays and optimizing panels to produce the most accurate detection rates of adenomas and colorectal cancers. We are making excellent progress towards an expected launch of a commercial product later this year for clinical use in detecting colorectal cancer. These latest findings, using an increased selection of NuQ® biomarker assays, augur well for VolitionRx's development of blood tests for the detection of other diseases, including lung and pancreatic cancers."
Hot Bio-Tech News
NAMUR, Belgium, May 12, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today announced that it is initiating a study with DKFZ, the German Cancer Research Center, to evaluate VolitionRx's NuQ® blood tests for the detection of pancreatic cancer.
This collaboration follows VolitionRx's announcements last year of highly encouraging data from two preliminary studies for pancreatic cancer detection. Results from a 59-patient trial with Lund University in Sweden, published in the journal Clinical Epigenetics, demonstrated a detection rate of 92% (23 of 25) of pancreatic cancer cases at 100% specificity using a panel of four NuQ® biomarker assays and the classical CA19-9 cancer biomarker. A second study with Hvidovre Hospital, University of Copenhagen in Denmark, demonstrated that a panel of two NuQ® biomarker assays and the classical cancer marker CEA (carcino-embryonic antigen) in an age and gender adjusted panel detected 95% (19 out of 20) of pancreatic cancers at 84% specificity.
Professor Hermann Brenner, epidemiologist at DKFZ said, "VolitionRx has demonstrated some very encouraging early results for pancreatic detection using the Company's NuQ® blood-based diagnostic tool. This larger trial with DKFZ will provide a more extensive opportunity to evaluate the effectiveness of Nucleosomics® technology for pancreatic cancer diagnosis, a high-unmet medical need worldwide."
Dr. Mark Eccleston, VolitionRx's Business Development Director, said, "We are delighted to be working with a world class institution such as DKFZ to advance our pancreatic cancer tests. Our preliminary studies indicate that NuQ® tests can identify disease-associated nucleosomes in the blood of patients with pancreatic cancer, and differentiate those from healthy populations as well as those with other benign pancreatic diseases. Our goal at VolitionRx is to complete this trial by the end of this year and if successful, to begin the regulatory work to sell clinically in 2017, starting in Europe."
VolitionRx's proprietary NuQ® blood tests are based on biomarker assays that can identify fragments of chromosomes, called nucleosomes, circulating in the blood and analyze them for epigenetic modifications that signal that cancer is present.
The five-year survival rate for pancreatic cancer is currently just 7.7%1, due to late diagnosis and the aggressive nature of the cancer. Screening for this cancer is only currently recommended for individuals considered at high risk of developing pancreatic cancer, as the only available methods are expensive or invasive techniques.2 CA19-9, the only blood based biomarker for pancreatic cancer, has relatively low accuracy and is therefore used mainly for monitoring treatment response and disease progression. Despite this limitation, there are still over 46 million CA 19-9 tests performed in the US, UK, Germany, France, Italy, Spain and Japan annually.3 Either replacing or augmenting this test would be the first target for VolitionRx in bringing a pancreatic blood test to market.
VolitionRx's Chief Executive Officer, Cameron Reynolds, added, "VolitionRx plans to launch its first commercial product, a blood test for colorectal cancer, later this year. Because our two preliminary trials for pancreatic cancer have produced such outstanding results, we anticipate this will be followed soon after by a NuQ® panel test for pancreatic cancer. This trial with DKFZ allows us to expand our analysis very quickly, with results expected by the end of the year, in a large sample set with a world class institution. If successful, this would be a game changing breakthrough in the diagnosis of this very deadly cancer."
Results from on-going clinical trials assessing the effectiveness of VolitionRx's biomarker assays, include:
Colorectal cancer and pre-cancerous colorectal adenomas
Interim results from a 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark), released September 9, 2015: Panel of four NuQ® biomarker assays detected 81% of colorectal cancers at 78% specificity and 67% of high-risk adenomas. (http://www.volitionrx.com/news/press-releases/detail/531/volitionrx-demonstrates-nuqr-blood-test-detects-81-of)
Results from a 59-patient retrospective study (Lund University, Sweden) published in Clinical Epigenetics online journal (http://www.clinicalepigeneticsjournal.com/content/pdf/s13148-015-0139-4.pdf), October 7, 2015: Panel of four NuQ® biomarker assays plus CA 19-9 classical biomarker detected 92% of pancreatic cancers at 100% specificity. (http://www.volitionrx.com/news/press-releases/detail/534/volitionrx-announces-publication-of-results-from-pancreatic)
Results from a 537-patient retrospective study (Surrey Cancer Research Institute at University of Surrey, United Kingdom), released April 20, 2016 at the AACR Annual Meeting: A single NuQ® biomarker assay detected 71% of early stage I prostate cancer cases and 86% of late stage IV prostate cancer at 93% specificity, which is significantly higher than the commonly-used PSA test reported to detect 53% of prostate cancers at 73% specificity. (http://www.volitionrx.com/news/press-releases/detail/561/volitionrx-announces-study-results-showing-nuq-blood-test)
Interim results (73 of 240 patients collected and assessed) from a prospective study (Liège University Hospital, Belgium), released November 19, 2015: Panel of four NuQ® biomarker assays detected 93% of lung cancers at 91% specificity and differentiated lung cancer from the common lung disease, COPD. (http://www.volitionrx.com/news/press-releases/detail/540/volitionrx-demonstrates-nuq-blood-test-detects-lung)
Results from a retrospective study of 78 patients referred for colonoscopy (Liège University Hospital, Belgium), released March 9, 2016: Preliminary data demonstrated 86% accuracy in detecting Idiopathic Pulmonary Fibrosis, a fatal lung disease, at 80% specificity. (http://www.volitionrx.com/news/press-releases/detail/551/preliminary-data-demonstrates-86-accuracy-in-detecting)
Comments & Business Outlook
https://www.sec.gov/Archives/edgar/data/93314/000107878216002787/f10q033116_10q.htm VOLITIONRX LIMITED
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Expressed in US dollars, except share numbers)
(Unaudited)
For the three months ended
March 31,
2016
$
For the three months ended
March 31,
2015
$
Revenue
–
–
Expenses
General and administrative
228,195
247,758
Professional fees
473,268
551,799
Salaries and office administrative fees
328,345
339,537
Research and development
1,462,820
1,210,782
Total Operating Expenses
2,492,628
2,349,876
Net Operating Loss
(2,492,628)
(2,349,876)
Other Income
Gain on derivative re-measurement
–
339,744
Net Other Income
–
339,744
Income taxes
–
–
Net Loss
(2,492,628)
(2,010,132)
Other Comprehensive Income/( Loss)
Foreign currency translation adjustments
18,380
(21,140)
Total Other Comprehensive Income/(Loss)
18,380
(21,140)
Net Comprehensive Loss
(2,474,248)
(2,031,272)
Net Loss per Share – Basic and Diluted
(0.13)
(0.12)
Weighted Average Shares Outstanding
– Basic and Diluted
19,289,484
16,461,816
Hot Bio-Tech News
NAMUR, Belgium, April 7, 2016 /PRNewswire/ -- VolitionRx Limited (NYSE MKT: VNRX) today announced CE marking for two blood-based diagnostic assays for the detection of colorectal cancer. The biomarker assays, NuQ®V001 and NuQ®T003, identify and analyze fragments of chromosomes, called nucleosomes, circulating within the blood for the presence of cancer signatures.
The two new CE marks follow the announcement last September of VolitionRx's first CE mark, which was for the NuQ®X001S biomarker assay for detecting colorectal cancer. Each of the three biomarker assays now CE marked represent a different family of NuQ® assays that target different features of nucleosomes, which consist of short strands of DNA wrapped around a core of eight histone proteins. The NuQ®T family of biomarker assays target the whole nucleosome. The other family members, NuQ®X and NuQ®V, target epigenetic cancer signals within the nucleosome, which affect gene activity without altering the DNA sequence. These include modifications to the DNA (targeted by the NuQ®X family of biomarker assays) and variations to the histone proteins (targeted by the NuQ®V family).
VolitionRx plans to offer a commercial test for colorectal cancer consisting of a panel of 4-6 individual NuQ® biomarker assays that require only a single drop of blood from patients. The Company is currently conducting ongoing clinical trials and following the CE compliance process for further biomarker assays in order to refine the make-up of the panel and produce the highest accuracy detection rates. VolitionRx anticipates launching a CE marked panel test for the detection of colorectal cancer for clinical use in Europe toward the end of 2016.
The announcement of the two new CE marks also follows the recent release of data from a 430-subject trial, which demonstrated that VolitionRx's NuQ® blood tests accurately detected 86% of early-stage colorectal cancers at 78% specificity, as well as 75% of high-risk colorectal adenomas, or pre-cancerous polyps that were most likely to become cancerous.
"We are delighted to announce CE marking for two new members of our family of NuQ® biomarker assays," commented Gaetan Michel, PhD, Chief Executive Officer of Belgian Volition SA. "In recent months, VolitionRx has achieved consistently excellent results for colorectal cancer detection using a panel test of NuQ® assays and has successfully detected both early- and late-stage cancer, which is critical for improving five-year survival rates. Since we announced our first CE marked biomarker assay last September, the Company has continued its strategic work toward additional CE marking that will allow us to deliver first-class quality products to physicians and their patients. Through this strategy, we have widened the span of discovery for relevant biomarkers and moreover broadened the potential use of our products. The CE marks mean that these NuQ® products are compliant with EU legislation and meet EU in-vitro diagnostic medical device requirements for clinical use in the European market."
"This CE marking is yet another very important milestone for the Company on our path to making our blood tests available to patients," added Cameron Reynolds, President and Chief Executive Officer of VolitionRx. "We are now able to sell three biomarker assays clinically in the 28 member states of the European Union, as well as Switzerland, Turkey, Iceland, Norway and Liechtenstein -- potentially reaching a population of nearly 600 million people including more than 150 million of screening age. We are currently in the process of CE marking other assays to finalise the panel for the anticipated European launch of our tests late this year. We are also progressing toward our goal of making our assays available for clinical use in the U.S. and the rest of the world. Due to the non-invasive, low-cost and patient friendly nature of NuQ® blood tests, we believe our technology has the potential to gain market acceptance and save lives in Europe, the U.S. and worldwide."
Results from on-going clinical trials assessing the effectiveness of VolitionRx's biomarker assays, include:
Colorectal cancer and pre-cancerous colorectal adenomas
Interim results from a 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark), released September 9, 2015: Panel of four NuQ® biomarker assays detected 81% of colorectal cancers at 78% specificity and also detected 67% of high-risk adenomas. (http://www.volitionrx.com/news/press-releases/detail/531/volitionrx-demonstrates-nuqr-blood-test-detects-81-of )
Results from a 59-patient retrospective study (Lund University, Sweden) published in Clinical Epigenetics online journal (http://www.clinicalepigeneticsjournal.com/content/pdf/s13148-015-0139-4.pdf), October 7, 2015: Panel of four NuQ® biomarker assays plus the CA 19-9 classical cancer biomarker detected 92% of pancreatic cancers at 100% specificity.(http://www.volitionrx.com/news/press-releases/detail/534/volitionrx-announces-publication-of-results-from-pancreatic)
Interim results (73 of 240 patients collected and assessed) from a prospective study (Liège University Hospital, Belgium), released November 19, 2015: Panel of four NuQ® biomarker assays detected 93% of lung cancers at 91% specificity and differentiated lung cancer from the common lung disease, COPD.(http://www.volitionrx.com/news/press-releases/detail/540/volitionrx-demonstrates-nuq-blood-test-detects-lung)
Results from a retrospective study of 78 patients referred for colonoscopy (Liège University Hospital, Belgium), released March 9, 2016: Preliminary data demonstrated 86% accuracy in detecting Idiopathic Pulmonary Fibrosis, a fatal lung disease, at 80% specificity.(http://www.volitionrx.com/news/press-releases/detail/551/preliminary-data-demonstrates-86-accuracy-in-detecting)
Notable Share Transactions
NAMUR , Belgium , March 23, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, announced today the closing of its previously announced underwritten public offering of 3,769,231 shares of common stock at a public offering price of $3.25per share, as well as 565,384 additional shares of its common stock pursuant to the full exercise of the over-allotment option granted to the underwriters. The net proceeds are expected to be approximately $12.8 million, after deducting underwriting discounts, commissions and estimated offering expenses payable by VolitionRx. All of the shares in the offering were offered by VolitionRx.
Notable Share Transactions
NAMUR, Belgium, March 17, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, announced today that it intends to offer and sell shares of its common stock in an underwritten public offering. VolitionRx intends to grant the underwriters an option to purchase an additional 15% of the shares of common stock sold in the offering, to cover over-allotments, if any. All shares of common stock in the offering are being offered by VolitionRx. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Raymond James & Associates, Inc. will act as the sole book-running manager for the proposed offering.
VolitionRx intends to use the net proceeds of the offering for continued product development, clinical studies, product commercialization, working capital, and for other general corporate purposes.
Deal Flow
Item 1.01 Entry Into A Material Definitive Agreement.
The Shares will be issued pursuant to an effective registration statement on Form S-3 (File No. 333-206781), which became effective on September 18, 2015, the base prospectus contained therein, and a related prospectus supplement filed with the Securities and Exchange Commission pursuant to Rule 424(b) of the Securities Act of 1933, as amended (the “Securities Act”).
The Offering is expected to close on or about March 23, 2016, subject to the satisfaction of customary closing conditions. The Underwriting Agreement contains customary representations, warranties and agreements by the Company, conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act, other obligations of the parties, lock-up and termination provisions.
The Underwriting Agreement has been attached hereto as an exhibit to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties in connection with the execution of the Underwriting Agreement.
The above description of the Underwriting Agreement is qualified in its entirety by reference to the full text of the Underwriting Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Stradling Yocca Carlson & Rauth, P.C., counsel to the Company, has issued an opinion to the Company, dated March 18, 2016, regarding the validity of the shares of common stock to be issued and sold in the Offering. A copy of the opinion is filed as Exhibit 5.1 to this Current Report on Form 8-K.
On March 17, 2016 and March 18, 2016, respectively, the Company issued press releases announcing the Offering and the pricing of the Offering. Copies of the press releases are attached as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.
Deal Flow
VOLITIONRX LIMITED
Shares of Common Stock
We are offering shares of our common stock. Our common stock is listed on the NYSE MKT under the symbol "VNRX." On March 16, 2016, the last reported sale price of our common stock was $3.54 per share.
As of March 16, 2016, the aggregate market value of our outstanding common stock held by non-affiliates was approximately $47,602,968, based on 18,863,272 shares of outstanding common stock, of which 5,416,106 shares are held by affiliates, and a per share price of $3.54 based on the closing sale price of our common stock as quoted on the NYSE MKT on March 16, 2016. As of the date hereof, including the securities being offered hereunder, we have offered securities with an aggregate market value of approximately $ pursuant to General Instruction I.B.6. of Form S-3 during the prior 12 calendar month period.
Investing in our common stock involves a high degree of risk. You should carefully review the risks and uncertainties described under the heading “Risk Factors” beginning on page S-6 of this prospectus supplement.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus supplement or the accompanying prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
______________________________
Per Share
Total
Public offering price
$
$
Underwriting discount(1)
$
$
Proceeds, before expenses, to us
$
$
(1) See “Underwriting” for additional disclosure regarding underwriting discounts, commissions and estimated offering expenses.
Cosmo Pharmaceuticals SA, or Cosmo, has indicated an interest in purchasing $3.0 million of shares of our common stock in this offering at the public offering price. Because this indication of interest is not a binding agreement or commitment to purchase, Cosmo may elect not to purchase any shares in this offering. The underwriters will receive the same underwriting discount on any shares purchased by Cosmo as they will on any other shares sold to the public in this offering. See the information included under the headings “Prospectus Supplement Summary—Recent Developments” and “Underwriting—Cosmo Pharmaceuticals SA.”
We have granted the underwriters an option for a period of 30 days from the date of this prospectus supplement to purchase up to an additional shares of common stock to cover overallotments at the public offering price, less underwriting discounts and commissions.
The shares will be ready for delivery on or about , 2016.
Comments & Business Outlook
NAMUR, Belgium, March 11, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, today announced financial results for the full year ended December 31, 2015.
Full Year 2015 Company Highlights:
Clinical
Colorectal cancer and adenomas:
Released interim data from first large-scale clinical trial, a 4,800-subject retrospective colorectal cancer study at Hvidovre Hospital, University of Copenhagen, Denmark. A panel of NuQ� biomarker assays detected 81% of colorectal cancers at 78% specificity equally well for both for early- and late-stage cancers and 67% of high-risk adenomas (polyps most likely to become cancerous).
Announced results from first completed prospective clinical trial in colorectal cancer. In the 121-patient study at CHU Dinant Godinne - UCL Namur in Belgium, a panel of 4 NuQ� biomarker assays, adjusted for age, detected 91% of colorectal cancers at 90% specificity. The study also detected 67% of high risk adenomas.
Pancreatic cancer:
Achieved first peer-reviewed validation of NuQ� test for pancreatic cancer published in journal Clinical Epigenetics . Results from a 59-patient retrospective study at Lund University, Sweden, showed a panel of four NuQ� biomarker assays plus CA 19-9 classical biomarker detected 92% of pancreatic cancers at 100% specificity.
Announced results from second preliminary study in pancreatic cancer based on the 4,800 patient clinical trial in Denmark, which included 20 subjects with pancreatic cancer. A 2-assay NuQ� panel plus classical cancer biomarker CEA achieved 95% sensitivity at 84% specificity.
Lung cancer:
Announced interim results from ongoing 240 patient trial evaluating NuQ� for the detection of lung cancer; when combined with smoking history, a 4-assay NuQ� panel accurately detected 93% of lung cancer cases at 91% specificity, and differentiated lung cancer from the common lung disease, COPD.
Regulatory
Announced first CE Mark for blood-based diagnostic assay, NuQ� X001S, for detection of colorectal cancer.
Operational
Listed the company on the New York Stock Exchange- MKT market and raised approximately $9.7 million in net proceeds in public offering of common stock.
Awarded two key U.S. patents: first (Number 9128086), relating to the detection of epigenetic changes that affect chromosome structure in cancer, by means of a simple test using a single drop of blood; and second (Number 9187780), relating to the measurement of nucleosome adducts (cancer-related proteins bound to nucleosomes).
Appointed David Kratochvil as Chief Financial Officer to lead the financial strategy in preparation for increased activity related to initial market entry of NuQ� tests in the U.S. and several markets worldwide.
Cameron Reynolds, President and Chief Executive Officer of VolitionRx, said, "2015 was a year of significant clinical and operational achievements for VolitionRxthat we believe set the Company on a path to long-term growth and success. Notably, we announced our first CE Mark (allowing European clinical sale) for the NuQ� X001S biomarker assay for detection of colorectal cancer. We are currently in the process of CE Marking the full panel of NuQ� biomarker assays that will comprise VolitionRx's colorectal cancer blood test, and are on track for the commercial launch of the test this year for clinical use in Europe, with meaningful sales expected to begin in 2017."
"In the fourth quarter, we released data from separate clinical trials showing that our NuQ� tests detect colorectal, pancreatic and lung cancers at early and late-stages with over 90% accuracy. In particular, we released highly promising results from the first completed prospective study in colorectal cancer patients. The study of 121-patients conducted at CHU Dinant Godinne - UCL Namur in Belgium included 23 cases of colorectal cancer. The study accurately detected 21 out of 23 of the colorectal cancer cases, achieving 91% sensitivity at 90% specificity based on a panel of 4 NuQ� biomarker assays. Moreover, the study demonstrated detection of 67% of high-risk adenomas, or pre-cancerous polyps that are most likely to become cancerous. These results highlight the potential of our NuQ� tests to accurately detect the entire range of cancer development from pre-cancerous polyps through early-stage to late-stage colorectal cancer. Last month, these results were followed up by encouraging results obtained from a 430 patient study, conducted at the Hvidovre Hospital and the University of Copenhagen in Denmark, which showed NuQ� biomarker assays detected 75% of high-risk colorectal adenomas."
"We have also made important progress in our pancreatic cancer program. The results of our first pancreatic cancer study with Lund University were published in the peer-reviewed journal, Clinical Epigenetics . We announced results of our second preliminary pancreatic cancer study with Hvidovre Hospital, University of Copenhagen in Denmark, which demonstrated that a 2-assay NuQ� panel plus classical cancer biomarker CEA detected 19 out of 20 pancreatic cancer cases (95% sensitivity) within a 4,800-subject trial at 84% specificity. These very encouraging results provide confidence to move forward with a large, dedicated pancreatic cancer study. We believe that pancreatic cancer represents a significant market opportunity, and expect that pancreatic cancer will be our second target indication for the commercialization of NuQ� , following colorectal cancer."
Mr. Reynolds continued, "Furthermore, the interim data from our 240 patient prospective lung cancer trial conducted at Liege University hospital was extremely promising. In total 73 patients were studied, including 29 with non-small cell lung cancer, 22 with the common lung disease COPD and 22 healthy subjects. A 4-assay NuQ� biomarker panel accurately detected 93% of lung cancer cases with only 2 false positives amongst the healthy subjects. Importantly, the test was also able to distinguish between lung cancer and COPD, and between cancerous and non-cancerous fibrous nodules in the lung. The best current lung cancer diagnostic, a low-dose computed tomography scan, does not distinguish well between cancerous and non-cancerous fibrous nodules in the lung, leading to a high false positive rate1 . Our interim data are exciting because they show both high sensitivity and very few false positives, indicating that a simple NuQ� blood test, used alone or in conjunction with current standards, may detect lung cancer and distinguish it from other lung diseases."
Mr. Reynolds added, "In the second half of 2015, our company was granted its first two U.S. patents for the detection of histone modification in cell-free nucleosomes and for methods of detection of nucleosomes adducts. These patents cover the core technologies of VolitionRx's Nucleosomics� platform: the measurement of cancerous changes to the nucleosomes themselves and the detection of cancer-related proteins bound to nucleosomes. In the first quarter of 2016, we were granted a third U.S. patent, relating to the detection of nucleosomes, which reinforces the Company's market exclusivity with its novel Nucleosomics� technology."
He concluded, "Overall, we accomplished a great deal in 2015 and have set in place the foundations for several key milestones in the year ahead. In addition to the European commercial launch of the NuQ� colorectal cancer test, we expect to initiate one or more large studies in both pancreatic and lung cancer and we will continue to report data from our ongoing colorectal cancer trials. We are grateful to our shareholders for their continued support and we are very excited about what the future holds."
Full Year 2015 Financial Results
For the full year ended December 31, 2015, VolitionRx reported a net loss of $9.5 million, or $0.54 per share. This compares to a net loss of $8.2 million, or $0.61 per share in full year of 2014.
Cash and cash equivalents as of December 31, 2015 totaled $5.9 million, compared with $2.1 million as of December 31, 2014 and $6.9 million as of September 30, 2015.
Hot Bio-Tech News
NAMUR, Belgium, March 9, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today announced preliminary data from a pilot study demonstrating that the Company's NuQ® blood test detected 86% of subjects with a deadly lung disease, called Idiopathic Pulmonary Fibrosis (IPF). This is the first set of results from a non-cancer trial of VolitionRx's NuQ® blood tests, which demonstrates the technology's potential as a diagnostic for other diseases.
The clinical study was conducted with Liège University Hospital in Liège, Belgium. Of the 78 subjects, 21 were non-treated patients with IPF, 27 patients had been treated for IPF, and 30 were healthy volunteers. Analysis of the preliminary data revealed that a single NuQ® biomarker assay detected 86% of the non-treated IPF patients (18 of 21) from the healthy subjects with only 6 false positives (80% specificity).
IPF is a chronic, progressive and lethal lung disease characterised by scarring and reduction in the lungs' capacity to absorb oxygen. In the United States, around 100,000 people are currently affected by IPF, with approximately 30-40,000 new cases diagnosed each year1. The true incidence rate is likely higher given current difficulties in proper diagnosis, classification and reporting.
Diagnosis of IPF is based on a range of clinical, laboratory, radiological and pathological tests, often to exclude other conditions first. The key diagnostic test currently available is High Resolution Computed Tomography (HRCT), a costly procedure to which access is limited in many countries. Current treatments include pulmonary rehabilitation, oxygen therapy, medication, and, in a small number of cases, lung transplants. The disease has a poor prognosis, with many patients surviving only 3-5 years after diagnosis1.
VolitionRx's Chief Scientific Officer, Dr. Jake Micallef, said, "Some NuQ® biomarker assays are particularly appropriate for the detection of inflammatory diseases such as IPF. To have achieved such impressive accuracy for detecting IPF using only a single such NuQ® biomarker assay in this pilot study is very encouraging. Our next step will be to work on a larger study sample and to include additional NuQ® biomarker assays to form a panel blood test that could have even greater accuracy."
Dr. Julien Guiot, project coordinator from Liège University Hospital, said, "At present, relatively little is known about this deadly disease. An accurate, cost-effective diagnostic for IPF could have a significant impact in assisting researchers in their efforts to understand the disease and develop a more viable treatment and potential cure."
Cameron Reynolds, Chief Executive Officer of VolitionRx, commented, "Our recent results show that panels of NuQ® biomarker assays can detect colorectal, lung and pancreatic cancers with more than 90% accuracy. The excitement generated by the success of these cancer-related clinical trials has led to interest from clinical partners to investigate the effectiveness of NuQ® blood tests in detecting other diseases, starting with IPF. We believe that the success of this pilot study for IPF demonstrates the potential of our Nucleosomics® technology as a diagnostic platform for a broad range of diseases and establishes a lucrative potential new market for VolitionRx. Moreover, we are excited that our non-invasive blood tests may assist in creating better outcomes for patients with this deadly disease."
Hot Bio-Tech News
NAMUR, Belgium, Feb. 17, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today announced results demonstrating that the Company's NuQ® blood test accurately detected 75% of colorectal adenomas, or pre-cancerous polyps, that were most likely to become cancerous. A panel of five of NuQ® biomarker assays also detected 86% of early (stage I) colorectal cancers. The completed clinical trial of 430 patients was conducted with the Hvidovre Hospital and with the University of Copenhagen in Denmark.
The study was specifically designed to assess the effectiveness of VolitionRx's NuQ® blood-based biomarker assays in detecting adenomas before they become cancerous, as well as early stage colorectal cancer. If adenomas are caught early enough and removed, the risk of subsequent cancer is significantly reduced.
The 430 patients, who either presented with symptoms suggesting the presence of colorectal cancer or were high-risk subjects, included 42 subjects with stage I cancer, 46 subjects with stage II cancer and 181 subjects with colorectal adenomas. No later stage cancers were included in the study. The trial was double blinded and age-adjusted; the results were at 78% specificity.
VolitionRx's proprietary NuQ® blood tests are based on biomarker assays that can identify fragments of chromosomes, called nucleosomes, circulating in the blood and analyze them for epigenetic modifications that signal that cancer is present. The final NuQ® test will likely consist of a panel of 4-6 individual biomarker assays that require only a single drop of blood from patients. During this trial, VolitionRx tested a number of new biomarker assays in order to refine the make-up of the panel and produce the highest accuracy detection rates.
Colorectal cancer is one of the most preventable cancers, yet there are still 50,000 deaths and more than 130,000 new cases diagnosed every year in the U.S. alone.1 Colonoscopy examinations provide a high percentage of detection, yet due to their invasive and costly nature, more than one third of adults of screening age in the U.S. are not screened with such a procedure.2 The five-year survival rate for colorectal cancer is 90% when detected at stage I but only 13% if detected at stage IV.
Professor Hans Jorgen Nielsen, Professor of Surgical Oncology at Hvidovre Hospital in Denmark, said, "This study shows extremely good detection of dangerous pre-cancer and early-stage cancer with the non-invasive NuQ® blood test. We are now working with VolitionRx on large retrospective and prospective trials in both screening and symptomatic populations. We expect to release more data from both these studies later this year."
VolitionRx's Chief Scientific Officer, Dr Jake Micallef, said, "Current blood tests and commonly used fecal tests are poor at detecting early stage colorectal cancer or pre-cancer, so we are very excited by these results. NuQ® tests are detecting early stage colorectal cancer and even pre-cancerous polyps that can be removed before cancer can develop. Finding tumors before they spread is a crucial breakthrough that has the potential to significantly improve the outcomes for colorectal cancer patients. In recent months, VolitionRx has identified and manufactured a number of new biomarker assays and now has a greater pool of NuQ® biomarker assay candidates from which to select the panel for the final blood test. These results demonstrate the increased accuracy from this optimization. We are now running these new biomarker assays in all our colorectal cancer trials."
Cameron Reynolds, Chief Executive Officer of VolitionRx, commented, "Not only do these results demonstrate our best detection rates to date for colorectal adenomas, but they further confirm the progress that VolitionRx is making in identifying new NuQ® biomarker assays and optimizing panels to produce the most accurate detection rates of adenomas and colorectal cancers. We are making excellent progress towards an expected launch of a commercial product later this year for clinical use in detecting colorectal cancer. These latest findings, using an increased selection of NuQ® biomarker assays, augur well for VolitionRx's development of blood tests for the detection of other diseases, including lung and pancreatic cancers."
Hot Bio-Tech News
NAMUR , Belgium , February 2, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today announced that it has initiated a study to assess the feasibility of using the Company's NuQ® blood tests to detect prostate cancer. The study is in collaboration with the Surrey Cancer Research Institute of the University of Surrey in the UK.
In the retrospective study, 550 blood samples collected from patients attending the hospital will be analyzed using a panel of VolitionRx's NuQ® biomarker assays. Three groups of patients will be assessed: those with aggressive prostate cancer; those with indolent or slow-growing prostate cancer; and age-matched healthy controls. In addition to determining the NuQ® blood test's accuracy in detecting prostate cancer, the study will also assess the tests' ability to distinguish among the different prostate conditions and healthy samples.
Approximately 14% of men will be diagnosed with prostate cancer at some point during their lifetime and nearly 3 million men are estimated to be living with prostate cancer in the United States alone1 . While more than 80% of all prostate cancers are detected at the local stage, and nearly 100% of men diagnosed and treated at this stage will be disease-free after five years, a small percentage of men experience more rapidly growing, aggressive forms of prostate cancer2 .
VolitionRx Chief Scientific Officer, Dr. Jake Micallef , commented, "I am pleased that we have been able to commence this work in collaboration with Professor Hardev Pandha from the University of Surrey , who is very experienced and well-known in the field of prostate cancer diagnostics. Early detection and the ability to differentiate men with aggressive tumors requiring immediate treatment from men with slow-growing tumors that do not require aggressive treatment are important goals in the field of prostate cancer research. This new study with the University of Surrey will investigate the use of NuQ® blood tests both for cancer detection and for selection of patients requiring aggressive treatment. This trial of our NuQ® biomarker assays for more general prostate cancer detection complements the study we have underway in collaboration with MD Anderson, in which we are focusing on anaplastic prostate cancer - one of the most aggressive forms."
Professor Hardev Pandha , Director of the Surrey Cancer Research Institute and Professor of Urological Oncology at the University of Surrey , remarked, "There is an unmet medical need for better diagnostics in prostate cancer. In particular, patient monitoring and selection for treatment currently relies predominantly on the invasive prostate biopsy. Based on the analysis we will conduct in this study and further evaluation in larger studies, it is our hope that VolitionRx's NuQ® tests will enable non-invasive and cost-effective blood-testing that will result in better diagnosis and treatment, and improved outcomes, for patients with prostate cancer."
Cameron Reynolds , Chief Executive Officer of VolitionRx, added, "We have now developed and manufactured a large suite of NuQ® biomarker assays which can be run rapidly using our high throughput ELISA robots at low cost. This allows us to investigate an expanding number of disease applications for our NuQ® tests while continuing to focus on the development and commercialization of regulatory approved products for colorectal cancer at very little extra cost."
In addition to this study, other clinical trials assessing the effectiveness of VolitionRx's biomarker assays in detecting prostate cancer include the following:
A retrospective study to establish the efficacy of VolitionRx's NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form (MD Anderson Cancer Center, Texas )
A 120-patient prospective feasibility study (ImmuneHealth, Belgium )
Results from ongoing clinical trials assessing the effectiveness of VolitionRx's assays, include:
Colorectal cancer and pre-cancerous colorectal polyps
Interim results from a 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen , Denmark), released September 9 2015: Panel of four NuQ® biomarker assays detected 81% of colorectal cancers and 67% of high-risk adenomas at 78% specificity
Results from a prospective study of 121 patient referred for colonoscopy (CHU Dinant Godinne - UCL Namur, in Belgium ), released December 8 2015: Panel of four NuQ® biomarker assays detected 91% of colorectal cancer cases at 90% specificity
Pancreatic cancer
Results from a 59-patient retrospective study (Lund University, Sweden ) published in Clinical Epignetics online journal (http://www.clinicalepigeneticsjournal.com/content/pdf/s13148-015-0139-4.pdf), October 7 2015: Panel of four NuQ® biomarker assays plus CA 19-9 classical biomarker detected 92% of pancreatic cancers at 100% specificity
Interim results from a 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen , Denmark), released October 22 2015: Panel of two NuQ® assays and the classical cancer marker CEA (carcino-embryonic antigen) distinguished 95% of pancreatic cancer cases from healthy subjects at 84% specificity
Lung cancer
Interim results (73 of 240 patients collected and assessed) from a prospective study (Liege University Hospital, Belgium ), released November 19 2015: Panel of four NuQ® biomarker assays detected 93% of lung cancers at 91% specificity
References
1. National Cancer Institute. "SEER Stat Fact Sheets: Prostate Cancer." November 2015 . Available online at: http://seer.cancer.gov/statfacts/html/prost.html. Accessed January 25, 2016 .
2. Prostate Cancer Foundation. "What is Prostate Cancer?" Available online at: http://www.pcf.org/site/c.leJRIROrEpH/b.5802045/k.6D36/What_Is_Prostate_Cancer.htm . Accessed January 25, 2016 .
Comments & Business Outlook
NAMUR , Belgium , January 28, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), today announced that the Company's subsidiary, Belgian Volition SA, has received the International Standards Organization (ISO) certification EN ISO 13485:2012 for its quality management system for the design, development, production and distribution of its NuQ® blood tests for a broad range of cancers.
EN ISO 13485:2012 certification relates to quality management systems in the field of medical devices, including in vitro diagnostic (IVD) devices. The EN prefix denotes that the certification is aligned with the three EU Medical Devices Directives (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices). VolitionRx's EN ISO 13485:2012 certificate was awarded by one of the world's leading certification bodies for the ISO, TUV-SUD, headquartered in Munich, Germany .
Dr. Gaetan Michel , Chief Executive Officer of Belgian Volition SA, stated, "ISO certification is a significant accomplishment and a key milestone for VolitionRx, demonstrating that the Company meets international regulatory standards and strict requirements for risk management and effective processes to design, manufacture and distribute our NuQ® blood tests. This certification allows VolitionRx to continue our focused efforts for the commercialization of NuQ® cancer tests in Europe and other major markets worldwide."
Cameron Reynolds , President and Chief Executive Officer of VolitionRx, said, "ISO certification affirms that our quality management system meets the highest standards and exemplifies VolitionRx's commitment to product quality. We anticipate bringing to market our first NuQ® blood-based cancer test, for clinical use in Europe this year and in the U.S. in 2017. Our goal is to enable accurate and affordable detection of early-stage cancer and to improve patient outcomes. I would like to congratulate the entire Belgian Volition team for the enormous amount of effort they have put into achieving this key organizational milestone."
Shareholder Letters
NAMUR , Belgium , Jan. 13, 2016 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, today released its annual update letter to its shareholders from CEO Cameron Reynolds . The letter provides a review of the Company's activities and milestones during 2015 and objectives for 2016.
In the letter, Mr. Reynolds outlines several key accomplishments over the previous year for the Company, including significant clinical advancements for its NuQ� blood-based testing programs for colorectal, pancreatic and lung cancers, for which test panels in all three indications have demonstrated more than 90% accuracy. In addition, Mr. Reynolds discusses the successful completion of VolitionRx's capital raise and listing on the NYSE MKT stock exchange that has allowed the Company to further develop its groundbreaking technology, CE Marking its first biomarker assay, NuQ� X001S, for detection of colorectal cancer that has set the stage for expected commercialization in 2016, and other key objectives.
The full letter is available on VolitionRx's website here:http://content.equisolve.net/volitionrx/media/8ccae86c1add41366ca15edc37654ef0.pdf.
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NAMUR , Belgium , December 8, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today announced results demonstrating that its NuQ® blood tests accurately detected 91% of colorectal cancer cases in a clinical study.
The study included 121 patients referred for colonoscopy at the university hospital, CHU Dinant Godinne - UCL Namur, in Belgium , who either presented with symptoms suggesting the presence of colorectal cancer or were high-risk subjects. Of these, 23 were found to have colorectal cancer. Investigators in the prospective study tested blood samples collected according to VolitionRx 's standard procedures, taken from subjects prior to their colonoscopy, to determine whether a NuQ® test could accurately predict the subsequent findings of the colonoscopy.
Analysis of the results revealed that a panel test of four NuQ® biomarker assays, adjusted for age, detected 91% of colorectal cancer cases at 90% specificity. In addition the results showed equally accurate detection of early- and late-stage cancers. The analysis also revealed that the same panel test detected 67% of the type of polyps most likely to develop into cancer, demonstrating a potential for NuQ® tests to accurately detect the complete spectrum of cancer development from pre-cancerous polyps through early-stage to late-stage colorectal cancer.
Colorectal cancer is one of the most preventable cancers, yet there are still 50,000 deaths and more than 130,000 new cases diagnosed every year in the U.S. alone1 . Colonoscopy examinations provide a high percentage of detection, yet due to their invasive and costly nature, more than one third of adults of screening age in the U.S. are not screened with such a procedure2 . The five-year survival rate for colorectal cancer is 90% when detected at stage I but only 13% if detected at stage IV.
Professor Lionel D'Hondt, Head of the Department of Oncology at CHU Dinant Godinne - UCL Namur, remarked, "The development of better methods for the early detection of colorectal cancer is critical for the improvement of patients' survival rates. We have found that a NuQ® panel test detects colorectal cancer and pre-cancer, with high accuracy, indicating it may be useful as a routine clinical colorectal cancer blood test."
VolitionRx Chief Scientific Officer, Dr. Jake Micallef , Ph.D., added, "Current screening options for colorectal cancer are limited to invasive endoscopy procedures and fecal tests. Neither of these methods is patient-friendly and their uptake by the population at large is poor. In contrast, a NuQ® panel test uses a tiny amount of blood and could be added to a routine medical check-up along with cholesterol, blood sugar, liver function, and other commonly administered blood tests. The study results demonstrate detection of 91% of colorectal cancer cases using an age-adjusted panel of four NuQ® assays. Moreover, 87% of colorectal cancer cases and 67% of high-risk dysplastic pre-cancerous polyps were detected using an unadjusted panel of five NuQ® assays alone, and no patient information. The study data provide evidence of the significant potential of our diagnostic NuQ® tests for detecting colorectal cancer."
Cameron Reynolds , Chief Executive Officer of VolitionRx, commented, "To detect colorectal cancer and pre-cancerous polyps with such high accuracy in an affordable blood test is a notable development. VolitionRx has demonstrated detection rates of 90% or higher in pancreatic cancer, lung cancer and now colorectal cancer, showing our unique proprietary platform technology can accurately detect a variety of cancers. Even more encouraging is the accuracy in detecting early-stage cancers and pre-cancers; finding tumours before they spread is a truly crucial breakthrough that will improve the outcomes for cancer patients."
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NAMUR , Belgium , Nov. 19, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today announced interim data demonstrating its NuQ� blood tests have accurately detected more than 90% of lung cancer cases in a study of 73 patients.
The clinical study is part of an ongoing larger prospective study of 240 subjects conducted with the Liege University Hospital (Belgium ). The results were the outcome of an interim analysis of the first subjects recruited, including 29 subjects diagnosed with Non-Small Cell Lung Cancer, 22 diagnosed with another pulmonary disease (COPD) and 22 with healthy lungs.
The analysis revealed that, when combined with details of smoking history, a panel of four NuQ� biomarker assays detected 93% of lung cancer cases (27 of 29), with 91% specificity (2 false positive results among 22 healthy subjects).
Lung cancer is the second most common cancer in men and women, with around 220,000 new cases diagnosed each year and 158,000 deaths in the U.S. alone1 . Lung cancer is the leading cause of cancer-related death in the U.S.2 . Smoking history is the most important of the known and proven risk factors for lung cancer. While there are several types of lung cancer, Non-Small Cell Lung Cancer represents about 80% of those detected3 . Typically, symptoms of lung cancer do not appear until the disease is already in an advanced stage, and they can be confused with others conditions. VolitionRx believes that there remains a high, unmet medical need for non-invasive and easy-to-use tests that detect early-stage cancer.
Professor Renaud Louis , Head of the Pneumology Department at Liege University Hospital (Belgium ), said, "These data show that Lung Cancer is detected by a NuQ� blood test and confirm the findings of our previous pilot study, which we presented at BioWin Day in November 2014. We look forward to the results of the completed study."
VolitionRx Chief Scientific Officer, Dr. Jake Micallef , Ph.D., remarked, "The NuQ� blood test not only differentiates lung cancer from healthy subjects but also from the common lung disease, COPD, which is related to tobacco consumption. The best current test for lung cancer is a scan that has high accuracy but does not distinguish well between cancerous and non-cancerous fibrous nodules in the lung, leading to a high false positive rate2 . Our interim data are exciting because they show both high sensitivity and very few false positives, indicating that a simple NuQ� blood test, used alone or in conjunction with current standards, may detect lung cancer and distinguish it from other lung diseases."
Cameron Reynolds , Chief Executive Officer of VolitionRx, added, "To be detecting more than 90% of cancers in this blinded trial is extremely exciting. VolitionRx's studies in colorectal cancer, pancreatic cancer and now lung cancer have consistently shown that our Nucleosomics� technology accurately detects cancers and is able to correctly distinguish among different diseases with a simple blood test. Using only a drop of blood, our NuQ� tests aim to be affordable, patient friendly, and to be as easy to use as they are simple to perform on existing hospital laboratory instruments."
VolitionRx expects to make full results of this ongoing lung cancer study available in 2016, as well as the results of another 600-subject lung cancer study conducted with the University Hospital Bonn in Germany .
In addition to this study, other clinical trials assessing the effectiveness of VolitionRx's biomarker assays include:
Colorectal cancer
A 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark)
A 14,000 patient prospective screening study (Hvidovre Hospital, University of Copenhagen, Denmark)
A 250 patient prospective study (CHU-UCL Mont Godinne Hospital, Belgium )
Pre-cancerous colorectal adenomas
A 800 patient retrospective study (Hvidovre Hospital, University of Copenhagen, Denmark)
27 most prevalent cancers
A 4,200 patient prospective study that involves patients with the 27 most prevalent cancers (University Hospital, Bonn, Germany )
Lung cancer
A 600 patient prospective confirmatory study (University Hospital, Bonn, Germany )
Prostate cancer
A retrospective study to establish the efficacy of VolitionRx's NuQ� tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form (MD Anderson Cancer Center, Texas )
A 120-patient prospective feasibility study (ImmuneHealth, Belgium )
Ovarian cancer
A 40-patient retrospective feasibility study (Singapore General Hospital, Singapore )
Endometriosis
A prospective study to assess VolitionRx's NuQ� tests for the diagnosis of endometriosis (the University of Oxford, United Kingdom )
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NAMUR , Belgium , November 17, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood tests for a broad range of cancer types and other conditions, today announced the grant of U.S. Patent Number 9187780 entitled "Method for Detecting Nucleosome Adducts."
The new U.S. patent, issued today and expiring in December 2032 , relates to VolitionRx's Nucleosomics® platform for the detection of changes in fragments of chromosomes, called nucleosomes. Scientists at VolitionRx have discovered that cancer-related proteins that form bonds with chromosomes in living cancer cells can also be detected and measured bound to nucleosomes circulating in the blood of cancer patients. The newly issued patent covers the methods for measuring these nucleosome-protein complexes, known as "adducts."
Dr. Jake Micallef , Chief Scientific Officer of VolitionRx, remarked, "This is a core technology patent for VolitionRx that we believe has an enormous potential application for non-invasive blood testing in cancer -- including the measurement of Estrogen Receptor Adducts and Androgen Receptor Adducts, which should be pivotal for the detection breast and prostate cancer disease respectively. The award of this second U.S. patent for the detection of proteins bound to nucleosomes, follows the recent award of our first U.S. patent covering measurement of cancerous changes to the nucleosomes themselves. The new patent is a further milestone in VolitionRx's progress to build up a world-wide portfolio of intellectual property to protect its Nucleosomics® technology. We continue towards our goal of bringing accurate and affordable detection of early-stage cancer in simple blood tests to market and helping as many patients as possible."
Cameron Reynolds , Chief Executive Officer of VolitionRx, added, "With the grant of a second patent in the U.S., VolitionRx is making progress toward commercializing our proprietary Nucleosomics® platform. The company is developing a world-wide portfolio of broad-reaching, wholly-owned and royalty-free patents to help protect the company's intellectual property estate and shareholder value. The VolitionRx-owned patent portfolio currently extends to eight patent families of issued and pending patents in market territories worldwide. Our scientific team is continuing to expand our patent portfolio and we expect further U.S. and other patent grants moving forward. I would also like to congratulate our Chief Scientific Officer, Dr. Micallef, who authored this patent, for his tireless work and vision during the past 6 years -- work that is now coming to fruition."
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Third Quarter 2015 Financial Results
For the three months ended September 30, 2015 , VolitionRx reported a net loss of $2.96 million , or $0.16 per share. This compares to a net loss of $5.89 million , or $0.44 per share in the third quarter of 2014
"In the last several months, we have made a number of substantial clinical and operational advancements, which we believe position the Company optimally for long-term growth and success. We reached an important milestone with the announcement of our first CE Mark for the NuQ® X001S biomarker assay for detection of colorectal cancer. This is the first of several biomarker assays we plan to CE Mark, which together would make up a commercial test for colorectal cancer. This should allow us the opportunity to commercialize the product in any of the 28 European Union member states and several other countries, representing an addressable market of more than 150 million people of screening age (50-75 years). We continue working closely with our market access consultants, DecideumCogentia and MedPass International, to optimize the launch and we expect to commercialize our NuQ® blood test for CRC in Europe in 2016," said Cameron Reynolds , President and Chief Executive Officer of VolitionRx.
"Additionally, in September, we released interim data from our 4,800 patient retrospective CRC study, which demonstrated NuQ® 's ability to detect colorectal cancer at all stages of disease progression, from pre-cancerous adenomas to early- and late-stage disease. The test achieved 81% sensitivity at 78% specificity equally well for both early- and late-stage cancers, plus, importantly, 67% of high-risk adenomas, which are defined as those most likely to become cancerous. These results, based on a panel of four NuQ® biomarker assays, are highly promising, and we look forward to the final results in early 2016. The full study results, which will analyze the sample set with an additional nine individual biomarker assays, will help us to optimize the panel for maximum sensitivity and specificity in the detection of colorectal cancer."
Mr. Reynolds added, "In the third quarter, we were also granted our first key U.S. patent, for the detection of histone modification in cell-free nucleosomes, which was previously granted in Europe . This patent, expiring in mid-2029, relates to the use of a simple, single-drop blood test to detect epigenetic changes that affect the chromosome structure in cancer, and is a significant addition to our notable intellectual property estate."
Mr. Reynolds further commented, "We have also made important progress in our pancreatic cancer program, which we expect will be our second marketed product behind colorectal cancer. After the close of the quarter, the results from our pilot study in pancreatic cancer with Lund University were published in the journal Clinical Epigenetics . Results demonstrated a panel of five NuQ® biomarker assays distinguished 92% of cancer cases with inclusion of the classical CA19-9 cancer biomarker and no false positives results among the healthy subjects. This was the first ever peer-reviewed publication of our panel approach to diagnostic test development and an important validation of our Nucleosomics® technology platform. In addition, we announced the results of our second preliminary pancreatic study, which included 20 pancreatic patients as well as healthy patients and those with other conditions, using a two-biomarker assay NuQ® panel and the traditional cancer biomarker CEA. The results, which demonstrated 95% sensitivity at 84% specificity, are extremely encouraging, and we expect will lead to larger clinical trials in pancreatic cancer as we move forward."
Mr. Reynolds concluded, "We made a key addition to our executive team with the appointment of David Kratochvil as Chief Financial Officer. With nearly 30 years of finance industry experience, David's leadership and contributions should be instrumental as we continue to advance toward commercialization. We are proud of our accomplishments thus far, are grateful to our shareholders for their continued support and look forward to achieving additional clinical and commercial milestones as we move into 2016."
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PR Newswire
Overall, the 4,800-patient retrospective study was conducted to detect colorectal cancer (CRC). However this patient cohort also included 166 patients who, although suspected for CRC, were found to have a different cancer. Of these 166 patients, 20 patients were diagnosed with pancreatic cancer.
Analysis of patients� blood samples demonstrated that a panel of two NuQ assays and the classical cancer marker CEA (carcino-embryonic antigen) distinguished 95% of pancreatic cancer cases from healthy subjects at 84% specificity.
Pancreatic cancer is one of the most deadly and difficult to detect and diagnose cancers, as the signs and symptoms are similar to many other illnesses. There are more than 40,000 deaths and over 50,000 new cases diagnosed each year in the U.S. alone, and the five-year survival rate for pancreatic cancer is currently just 7%1 . Pancreatic cancer is projected to become the second leading cause of cancer-related death in the U.S. by 20302 .
VolitionRx Chief Scientific Officer, Dr. Jake Micallef, commented, Although this study was not designed specifically as a pancreatic cancer study and the NuQ assays used were not tailored for pancreatic cancer detection, it is very encouraging that a NuQ panel test nonetheless detected nearly all the pancreatic cancer cases in this patient set. This substantiates the highly encouraging results from our previous pancreatic cancer trial that were recently published in the journal Clinical Epigenetics .�
Existing screening tests for pancreatic cancer are far from ideal, and tend to be either very invasive, expensive or inaccurate. VolitionRx strongly believes that blood-based testing for pancreatic and other cancers is the best platform for screening patients. These results provide compelling evidence that VolitionRx has an accurate, cost-effective, non-invasive, blood-based solution for pancreatic cancer diagnosis, concluded Dr. Micallef.
VolitionRx Chief Executive Officer, Cameron Reynolds, added, We now have confirmation of pancreatic cancer detection at a very high rate, in two completely different patient sets collected independently in different countries. Moreover, this second patient set is a large sample set. These very encouraging results provide significant confidence to move forward with a large, dedicated pancreatic cancer study. At this time, we believe pancreatic cancer has the highest likelihood of being the second cancer for which we bring a NuQ panel test to market, following CRC. Pancreatic cancer is deadly and currently very difficult to diagnose early, and we hope to provide a solution to this high unmet medical need.
The pancreatic cancer results from the Danish study compare favorably with the recently published results from VolitionRx�s trial with Lund University in Sweden, which demonstrated a detection rate of 92% (23 of 25) of cancer cases at 100% specificity using a panel of four NuQ� assays and the classical CA19-9 cancer biomarker. Full details were published in the journal Clinical Epigenetics :http://www.clinicalepigeneticsjournal.com/content/pdf/s13148-015-0139-4.pdf.
Last month, VolitionRx announced interim CRC results from the 4,800-subject trial at Hvidovre Hospital, which indicated that its NuQ� blood tests detected 81% of colorectal cancers at 78% specificity equally well for both for early- and late-stage cancers.
The NuQ tests utilize the Company�s proprietary Nucleosomics� technology platform, which identifies and measures circulating fragments of DNA, called nucleosomes, for the presence of epigenetic cancer signals within the blood. Full details of ongoing clinical trials can be found at http://www.volitionrx.com/technology/clinical-trials-collaborations.
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NAMUR , Belgium , October 12, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today announced that full results from a completed clinical study of its NuQ® blood-based test for early stage pancreatic cancers have been published in the online issue of Clinical Epigenetics , the official journal of the Clinical Epigenetics Society. The peer-reviewed study was conducted in collaboration with Lund University, Sweden , and led by Roland Andersson , MD, PhD, Professor of Surgery and Vice-Dean, Faculty of Medicine.
The study assessed blood samples from 59 individuals, including 25 patients with stage 2 pancreatic cancer, 10 patients with other pancreatic diseases and 24 healthy individuals, using VolitionRx's Nucleosomics® technology platform. Analysis of the blood samples demonstrated that a panel of five NuQ® assays distinguished 84% (21 of 25) of the early-stage pancreatic cancer cases from healthy subjects, with only two false positive results among the healthy subjects. The detection rate of the test was improved further to 92% (23 of 25) of cancer cases by inclusion of the classical CA19-9 cancer biomarker with no false positives results among the healthy subjects. Full details are available in the publication: http://www.clinicalepigeneticsjournal.com/content/pdf/s13148-015-0139-4.pdf
This is the first peer reviewed validation of VolitionRx's panel approach to diagnostic test development.
Pancreatic cancer is one of the most deadly cancers. There are more than 40,000 deaths and over 50,000 new cases diagnosed each year in the U.S. alone1 . In addition, pancreatic cancer is projected to become the second leading cause of cancer-related death in the U.S. by 20302 . Pancreatic cancer is difficult to detect and diagnose because there aren't any noticeable signs or symptoms in the early stages of pancreatic cancer. The signs and symptoms of pancreatic cancer, when present, are like the signs and symptoms of many other illnesses. The five-year survival rate for pancreatic cancer is currently just 7%1 . However, these cancers are typically detected at late-stage after the onset of symptoms. VolitionRx believes that there remains a high unmet medical need for tests that detect early-stage cancer and are also non-invasive and easy to use.
VolitionRx Chief Executive Officer Cameron Reynolds , commented, "This is a very important milestone for VolitionRx. To our knowledge, this study is the first to describe the epigenetic profiling of nucleosomes circulating in the blood for the detection of pancreatic cancer, making its publication a significant achievement in the field of blood-based cancer detection. These results demonstrate that our NuQ® tests can accurately and distinctly detect differing levels and epigenetic profiles of nucleosomes in the blood of patients with pancreatic cancer, and differentiate those from healthy populations as well as those with other benign pancreatic diseases. Furthermore, the study confirms nucleosome profiles as distinguished by our NuQ® tests represent potential biomarkers for the early detection of cancer with very good accuracy. We are in the process of negotiating large trials to confirm these extremely encouraging results from this pilot study."
Dr. Roland Andersson , MD, PhD, Professor of Surgery Vice Dean, Faculty of Medicine at Lund University, Sweden , added, "Pancreatic cancer has a poor prognosis, with a five-year survival rate of only 6-7 percent, mainly due to the asymptomatic nature of its early stages, aggressive biological behavior, and limitations of current detection technologies. Our pilot study shows that VolitionRx's NuQ® blood-based diagnostic tool accurately detects and distinguishes patients with pancreatic cancer from those with benign cases and from healthy patients. On a practical level, these are tests that use a single, small volume of blood and have potential as a valuable screening option, as the test is able to detect with high sensitivity even early stages of disease."
VolitionRx Chief Scientific Officer Dr. Jake Micallef said, "The complete dataset confirms the significant clinical accuracy for our NuQ® assays in detecting pancreatic cancer and futher validates nucleosomes as biomarkers with their rich variety of available epigenetic features that allow for fine-tuning of sensitivity and specificity. In addition, the study showed that the assays' accuracy could be further improved by combining VolitionRx's nucleosome biomarkers with the well-established CA19-9 biomarker, considered the benchmark to which all new investigational biomarkers are compared, to produce highly specific, clinically-sensitive biomarker panels."
The NuQ® tests utilize the Company's proprietary Nucleosomics® platform, which identifies and measures circulating nucleosome structures for the presence of epigenetic cancer and signals within the blood.
In addition to the published data from the study evaluating NuQ® in pancreatic cancer, clinical trials assessing the effectiveness of VolitionRx's assays include:
Colorectal cancer
A 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen , Denmark)
A 14,000 patient prospective screening study (Hvidovre Hospital, University of Copenhagen , Denmark)
A 250 patient prospective study (CHU-UCL Mont Godinne Hospital, Belgium )
Pre-cancerous colorectal adenomas
A 800 patient retrospective study (Hvidovre Hospital, University of Copenhagen , Denmark)
27 most prevalent cancers
A 4,200 patient prospective study that involves patients with the 27 most prevalent cancers (University Hospital, Bonn, Germany )
Lung cancer
A 600 patient prospective confirmatory study (University Hospital, Bonn, Germany )
Prostate cancer
A retrospective study to establish the efficacy of VolitionRx's NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form (MD Anderson Cancer Center, Texas )
A 120-patient prospective feasibility study (ImmuneHealth, Belgium )
Ovarian cancer
A 40-patient retrospective feasibility study (Singapore General Hospital, Singapore )
Endometriosis
A prospective study to assess VolitionRx's NuQ® tests for the diagnosis of endometriosis (the University of Oxford, United Kingdom )
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NAMUR , Belgium, September 22, 2015 /PRNewswire / --VolitionRx Limited (NYSE MKT: VNRX) today announced the Company's first CE Mark for its blood-based diagnostic assay, NuQ® X001S, for detection of colorectal cancer. The NuQ® test utilizes the Company's proprietary Nucleosomics® technology platform, which identifies and analyses fragments of chromosomes, called nucleosomes, circulating within the blood for the presence of epigenetic cancer signals.
The NuQ® X001S assay is the first to be CE Marked out of a suite of NuQ® assays developed by VolitionRx targeting different epigenetic modifications that indicate that cancer is present. The Company plans to offer a commercial test consisting of a panel of 4-6 individual ELISA assays; it is currently conducting ongoing clinical trials and following the CE compliance process on further assays in order to refine the make-up of the panel and produce the highest accuracy detection rates. VolitionRx anticipates launching its panel of CE Marked assays for clinical use in Europe during 2016.
This announcement follows the presentation earlier this month of interim data of a 4,800-subject trial, which demonstrated that VolitionRx's NuQ® blood tests detected 81% of colorectal cancers at 78% specificity equally well for both for early- and late-stage cancers, as well as 63% of potentially pre-cancerous adenomas and 67% of high-risk adenomas - the most likely to become cancerous.
Gaetan Michel , PhD, Chief Executive Officer of Belgian Volition SA, commented, "Our recent results showed that a panel test of 4 NuQ® assays successfully detected both early- and late-stage cancer well, which is critical for improving five-year survival rates. Achieving the first CE mark for our NuQ® X001S diagnostic assay demonstrates VolitionRx's clear commitment to deliver these first-class quality products to physicians and their patients. The CE Mark means that this NuQ® product is compliant with EU legislation and meets EU in-vitro diagnostic medical device requirements for clinical use in the European market. Due to the non-invasive, low-cost and patient friendly nature of NuQ® blood tests, we believe our technology has the potential to gain market acceptance and save lives in Europe and worldwide."
Cameron Reynolds , President and Chief Executive Officer of VolitionRx, added, "This is yet another very important milestone for the Company on our path to making our blood tests available to patients. We are now able to sell this assay clinically in the 28 member states of the European Union, as well as Switzerland , Turkey , Iceland , Norway and Liechtenstein - an area with a total population of nearly 600 million people including over 150 million of screening age. We are currently in the process of CE marking other assays to finalise the panel for the anticipated European launch of our tests in 2016. We are proud of the thorough scientific and operational development of our NuQ® colorectal cancer tests and I would particularly like to thank our whole team who, through years of dedication and commitment, have made this key milestone possible. We also aim to continue to progress in 2016 towards our goal of making our assays available for clinical use in the U.S. and the rest of the world."
VolitionRx currently has several ongoing clinical trials assessing the effectiveness of its NuQ® assays. The full list includes:
Colorectal cancer
A 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen , Denmark)
A 14,000 patient prospective screening study (Hvidovre Hospital, University of Copenhagen , Denmark)
A 250 patient prospective study (CHU-UCL Mont Godinne Hospital, Belgium )
Pre-cancerous colorectal adenomas
A 800 patient retrospective study (Hvidovre Hospital, University of Copenhagen , Denmark)
27 most prevalent cancers
A 4,200 patient prospective study that involves patients with the 27 most prevalent cancers (University Hospital, Bonn, Germany )
Lung cancer
A 600 patient prospective confirmatory study (University Hospital, Bonn, Germany )
Prostate cancer
A retrospective study to establish the efficacy of VolitionRx's NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form (MD Anderson Cancer Center, Texas )
A 120-patient prospective feasibility study (ImmuneHealth, Belgium )
Ovarian cancer
A 40-patient retrospective feasibility study (Singapore General Hospital, Singapore )
Endometriosis
A prospective study to assess VolitionRx's NuQ® tests for the diagnosis of endometriosis (the University of Oxford, United Kingdom )
VolitionRx has applied the CE Mark to its blood-based diagnostic assay, NuQ® X001S , in agreement with the IVD Directive 98/79/EC and the Company has notified the product to the Competent Authorities.
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NAMUR , Belgium , September 10, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood tests for a broad range of cancer types and other conditions, today announced the grant of US Patent Number 9,128,086 entitled "Detection of Histone Modification in Cell-Free Nucleosomes". This patent is already issued in Europe to the Company under the number EP1668368B1.
The key new U.S. patent, issued yesterday and expiring in mid-2029, relates to the detection of epigenetic changes that affect chromosome structure in cancer, by means of a simple test using a single drop of blood. VolitionRx's Nucleosomics® platform detects changes to histone proteins contained in fragments of chromosomes, called nucleosomes, that circulate in the blood of cancer patients.
Dr. Jake Micallef , Chief Scientific Officer of VolitionRx, remarked, "VolitionRx is building a world-wide portfolio of intellectual property to protect its Nucleosomics® technology for detecting cancer and other diseases in blood samples and biological fluids. The grant of U.S. Patent 9,128,086 provides protection to key technology that underpins our NuQ® tests as we continue towards our goals of commercialization and helping as many patients as possible."
Cameron Reynolds , Chief Executive Officer of VolitionRx, added, "Our first granted patent in the U.S. is a key milestone for VolitionRx in our path to commercialization of our proprietary Nucleosomics® platform. Since the Company's inception, our mission has been to develop accurate and cost-effective detection tools for early-stage cancer and other conditions. We have made great progress through exhaustive work in R&D and clinical trials. The grant of this broad-reaching, wholly-owned and royalty-free patent is a critical step in protecting VolitionRx's intellectual property and consequently shareholder value."
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NAMUR, Belgium, Sept. 9, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX) today announced interim results from its 4,800-subject retrospective colorectal cancer trial at Hvidovre Hospital, University of Copenhagen, and at six collaborating hospitals (Bispebjerg, Herning, Hilleroed, Horsens, Randers and Viborg) in Denmark. The interim data indicates that VolitionRx's NuQ® blood tests detected 81% of colorectal cancers at 78% specificity equally well for both for early- and late-stage cancers. In addition, the tests detected 63% of potentially pre-cancerous adenomas (or polyps) including, most importantly, 67% of high-risk adenomas (the most likely to become cancerous). The preliminary results of this double blinded and independent trial demonstrate the NuQ® test's potential to detect cancers over the complete spectrum of development, from pre-cancerous adenomas through early-stage to late-stage colorectal cancer.
The results will be presented today at 1:45 p.m. EDT during the Rodman & Renshaw 17th Annual Global Investment Conference in New York (webcast live at http://wsw.com/webcast/rrshq25/vnrx and archived for at least 90 days athttp://www.volitionrx.com/news/events-calendar), and will also be presented at the CNAPS (Circulating Nucleic Acids in Plasma and Serum) IX Conference in Berlin on Friday, September 11 at 3:05-3:25 p.m. CEST.
Colorectal cancer is one of the most preventable cancers, yet there are still 50,000 deaths and over 130,000 new cases diagnosed every year in the U.S. alone1. Colonoscopy examinations provide a high percentage of detection yet, due to their invasive and costly nature, more than one third of adults of screening age in the U.S. refuse to be screened with such a procedure2. The five-year survival rate for colorectal cancer is 90% when detected at Stage I but only 13% if detected at Stage IV. However, these cancers are typically detected at late-stage after the onset of symptoms. VolitionRx believes that there remains a high unmet medical need for tests that detect early-stage cancer and are also non-invasive and easy to use.
VolitionRx's simple, cost-effective, non-invasive, NuQ® colorectal cancer blood test is expected to consist of a panel of 4-6 individual ELISA assays. A function of the 4,800 subject trial is to optimize the composition of this panel; the amount of patient's blood serum available for the trial will allow up to 20 assays to be run per patient. The interim data gives results for the 4,800 samples using a panel of four NuQ® assays chosen from the nine candidate assays that VolitionRx has manufactured on a large scale and run in this trial to date. The full study will analyze the sample set with up to 11 additional assays that are currently being finalized, to further refine the choice of assays in the panel to produce the highest accuracy detection rates.
Professor Hans Jorgen Nielsen, Professor of Surgical Oncology at Hvidovre Hospital in Denmark, who is leading the study, commented, "These interim results are compelling, particularly those demonstrating high sensitivity for detecting early-stage colorectal cancer and potentially pre-cancerous adenomas. Most blood-based cancer biomarkers are more effective at detection of large late-stage cancers than small early-stage cancers, and very poor at detecting pre-cancer. The ability to detect both early and late stage cancers, as well as high risk pre-cancer, is critical in demonstrating the value of the NuQ® test, as this may enable more cost-effective and successful patient outcomes. We look forward to providing an update on further results from this study, as well as results from an ongoing prospective 14,000 colorectal cancer patient screening study, for which the first 2,500 patient samples have already been collected and are currently being analyzed."
Cameron Reynolds, President and Chief Executive Officer of VolitionRx, added, "We are very excited to report such strong results in our first large clinical trial and will continue to analyze the samples using up to 11 additional assays. We are looking for even better assay candidates and still have two key target assays to scale up for manufacturing for the next round of testing. We believe that this will enable us to develop the best panel of assays with the highest sensitivity and most accurate detection rates for early- and late-stage cancer. We anticipate providing the full data set for the 4,800-subject retrospective study in the first quarter of 2016. Given the strength of this interim data we are also moving forward aggressively with the CE marking of our products to enable them to be sold for clinical use in Europe and to begin the process in the U.S. with the FDA."
Interim sensitivity findings for cancer and the possibly pre-cancerous adenoma in this 4,800-subject population type are outlined as follows:
Cancer
Sensitivity
N=
Colorectal cancer
81%
401 out of 498
Adenomas
63%
415 out of 655
High risk adenomas
67%
256 out of 383
High neoplasia adenomas
68%
76 out of 111
Villous adenomas
73%
8 out of 11
Serrated adenomas
80%
24 out of 30
Importantly, the assays are not stage dependent. All results are age and gender adjusted, measured at 78% specificity against high risk or symptomatic patients who are otherwise healthy subjects referred for colonoscopy but found to have no bowel lesions or other comorbidities.
The NuQ® tests utilize the Company's proprietary Nucleosomics® technology platform, which identifies and measures circulating nucleosome structures for the presence of epigenetic cancer signals within the blood.
The full list of ongoing clinical trials assessing the effectiveness of VolitionRx's assays, including the 4,800-subject trial discussed here, include:
Colorectal cancer
A 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark)
A 14,000 patient prospective screening study (Hvidovre Hospital, University of Copenhagen, Denmark)
A 250 patient prospective study (CHU-UCL Mont Godinne Hospital, Belgium)
Pre-cancerous colorectal adenomas
A 800 patient retrospective study (Hvidovre Hospital, University of Copenhagen, Denmark)
27 most prevalent cancers
A 4,200 patient prospective study that involves patients with the 27 most prevalent cancers (University Hospital, Bonn, Germany)
Lung cancer
A 600 patient prospective confirmatory study (University Hospital, Bonn, Germany)
Prostate cancer
A retrospective study to establish the efficacy of VolitionRx's NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form (MD Anderson Cancer Center, Texas)
A 120-patient prospective feasibility study (ImmuneHealth, Belgium)
Ovarian cancer
A 40-patient retrospective feasibility study (Singapore General Hospital, Singapore)
Endometriosis
A prospective study to assess VolitionRx's NuQ® tests for the diagnosis of endometriosis (the University of Oxford, United Kingdom)
Deal Flow
CALCULATION OF REGISTRATION FEE
Title of Each Class of Securities to be Registered
Amount to be (1)
Proposed (1)
Proposed (1)(4)
Amount of (4)
Common stock, $0.001 par value per share(2)
-
-
Preferred stock, $0.001 par value per share(2)
Warrants(3)
Total
$
50,000,000
$
5,810
CFO Trail
NAMUR, Belgium, August 17, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, today announced the appointment of David Kratochvil as its Chief Financial Officer and Treasurer, effective August 17, 2015 . Kratochvil joins VolitionRx to lead the Company's financial strategy in preparation for increased activity related to initial market entry of its NuQ® tests in the U.S. and several markets worldwide. Kratochvil replaces Mike O'Connell , who has served as Chief Financial Officer and Treasurer on a consulting basis since July 2014 through Isosceles Finance Limited, an accounting services company he founded in 2001.
"David is an accomplished U.S.-based executive who brings a wealth of financial and capital markets expertise, and we are excited to have him join our team," said Cameron Reynolds , President and Chief Executive Officer of VolitionRx. "We are approaching a number of key inflection points in the coming months and recognized the importance of enhancing our executive suite to effectively leverage the opportunities that lie ahead. David's addition further strengthens the leadership within the organization, especially in the U.S., and we look forward to his contributions as we continue working toward several anticipated milestones. His very lengthy capital market experience, coupled with his strong financial background, were the key factors in his appointment to this critical role."
Kratochvil brings more than 28 years of broad financial sector experience and leadership to his role at VolitionRx. He joins the Company from Euro Pacific Capital, where he served as Managing Director in the Corporate Finance department overseeing the firm's investment banking efforts across a variety of sectors. At Euro Pacific since 2008, Kratochvil also served as Director of Research where he managed a team of equity analysts and increased research coverage.
Prior to Euro Pacific, Kratochvil had a lengthy career analyzing and investing in international securities. He was an international portfolio manager at Omega Advisors where he analyzed, executed and monitored investments across a variety of asset classes. Prior to joining Omega, he was a Director at Merrill Lynch Asset Management in London where he invested throughout emerging European markets. Additionally, Kratochvil founded his own advisory firm, Vista Capital Advisors, to provide global investment advice. He also worked as an equity analyst in New York , a private equity investor in Prague , and as a business tax consultant in New York .
Kratochvil earned a Master of Business Administration (MBA) in Finance and International Business from the University of Chicago's Booth School of Business, and he holds a Bachelor of Science in Economics (BS Econ) with specialization in Finance and Accounting from University of Pennsylvania's Wharton School.
"I am grateful to Cameron and the VolitionRx Board for the opportunity to join such a vibrant and motivated management team that has built VolitionRx from the ground up in the past five years," said Kratochvil. "NuQ® and the Company's proprietary Nucleosomics® technology platform have the potential to redefine the early detection of many types of cancer, make a significant impact on the industry and, most importantly, the lives of patients. I aim to give the Company a very strong focus on U.S. financial markets and assist in the business planning and financial modelling to launch the suite of NuQ® products worldwide."
O'Connell added, "I look forward to continuing my work with VolitionRx to ensure a smooth transition of the CFO role to David, and over the longer term, to providing Group Financial Controller services through Isosceles Finance. Given the progress that VolitionRx has made in recent years and anticipated future milestones, engaging a full-time CFO was an important next step in the Company's evolution."
Comments & Business Outlook
Second Quarter 2015 Financial Results
Net loss of $1.9 million , or $0.10 per share. This compares to net income of $0.8 million , or $0.06 per share in the second quarter of 2014.
"In the last several months, we have continued advancing trials in a range of cancers including our large independent colorectal cancer trials. We remain on track to announce the next big tranche of data in the coming months. We also aim to receive our first CE mark by the end of the year. Concurrently, we have made progress toward developing a commercial organization capable of bringing our NuQ® blood tests to market in the U.S. and Europe ," said Cameron Reynolds , President and Chief Executive Officer of VolitionRx.
"We are pleased to be working with two prominent market access consulting agencies, DecideumCogentia and MedPass International, to optimize the launch of our NuQ® cancer tests across Europe once we gain CE Mark approval. We expect to have a CE Mark on our first NuQ® colorectal assay by the end of this year, gain CE Mark approval on the full panel by the middle of 2016 and achieve the first meaningful volumes of sales beginning in 2017. Our recently announced engagement of GSS is expected to accelerate our entry into the U.S. market through relationships with select CLIA regulated labs and medical universities. We continue working toward FDA approval of the NuQ® colorectal cancer diagnostic. In addition, we recently expanded and strengthened our Scientific Advisory Board with the addition of four leading physicians and industry specialists. These individuals bring a wealth of clinical and commercial expertise to our team, which we believe will be valuable as we advance from clinical development to commercialization in Europe and the U.S."
Reynolds added, "We now have our new Tecan automated laboratory robots operational, and expect to reach full capacity next month. This will enable us to process as many as 60,000 patient samples per month, compared to 2,000 samples per month via the manual processing methods we used previously. The throughput improvements we gain with these machines will be key as we continue advancing our NuQ® trials. We continue to explore the potential to develop our Nucleosomics® biomarker panels for other types of cancer. In addition, we aim to secure larger trials in lung, prostate and pancreatic cancer and hope to announce progress this year, supported by the promising results we have reported in our pilot studies in these cancers. At the end of the quarter, VolitionRx had cash of $9.3 million , having raised approximately $9.7 million in net proceeds from a public offering at the time of our NYSE MKT listing in February 2015 . We expect another very productive second half of the year for VolitionRx with several key milestones within reach."
Hot Bio-Tech News
NAMUR, Belgium, July 27, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, today announced that it has engaged the services of a specialty specimen management clinical research organization, Global Specimen Solutions, Inc. (GSS), to support initial U.S. market entry of its NuQ® colorectal cancer tests.
Under the agreement, GSS will target and select U.S. medical universities and U.S. commercial clinical laboratories providing diagnostic testing services regulated under the Clinical Laboratory Improvement Amendments (CLIA) as strategic collaboration partners for testing of VolitionRx's NuQ® colorectal cancer tests. GSS will also develop a strategic market access plan for implementing relationships with select CLIA regulated labs, including licensing and royalty modeling from CLIA Laboratory Developed Tests (LDT) development, and strategic regulatory and clinical development for Premarket Approval (PMA) submission with the Food and Drug Administration (FDA).
Through partnership with GSS, VolitionRx aims to license its Nucleosomics® biomarker panels to CLIA labs for LDT development in the U.S. in 2016.
Cameron Reynolds, Chief Executive Officer of VolitionRx, commented, "With world-class expertise in collecting and managing specimens for research, and a strong understanding of the technology trends, regulatory environment and competitive situation, GSS is an ideal partner to support VolitionRx's strategy to enter the U.S. market and gain FDA approval of our NuQ® colorectal cancer tests. By first partnering with GSS to enter CLIA-certified labs and medical universities in the U.S., we believe that we will be well-positioned to initiate a bridging U.S. FDA-endorsed trial with our ongoing large trials in Europe, which will be designed to provide the clinical data to support PMA submission for the potential FDA approval of our NuQ® tests for the early detection of colorectal cancer. In parallel, we aim to license our Nucleosomics® biomarker panels in the US for development as an LDT in 2016, and provide VolitionRx with early revenue, while proceeding with the FDA approval process."
Gerald J. Vardzel, Vice President of Corporate Development at Global Specimen Solutions, commented, "VolitionRx's innovative blood-based cancer tests offer a potentially viable solution for detecting cancer early to allow more effective treatments. We look forward to supporting VolitionRx regarding strategic decisions to assess the value of its Nucleosomics® platform; providing insights on our understanding of technology trends, regulatory environment and competitive situation; and introducing VolitionRx to select medical universities and CLIA labs for collaborations aimed at initial entry into the U.S."
Mark Eccleston, PhD, MBA, Business Development Director at VolitionRx, added, "Collaborating with GSS in the U.S. augments our primary commercialization strategy to gain approvals in both Europe and the U.S. in alignment with swift market entry across these regions. Our objective is to work with GSS to identify and select key U.S. partners to develop our Nucleosomics biomarkers as an LDT and we look forward to providing further updates on this process."
Amelia Warner, PharmD, RPh, CEO and Founder of GSS, commented, "We are extremely excited about collaborating with VolitionRx on this promising technology. GSS is looking forward to building a long-term relationship with VolitionRx to help roll out their disruptive technology platform into the clinic where we hope to impact current patient care."
The NuQ® tests will utilize VolitionRx's proprietary Nucleosomics® technology platform, which identifies and measures circulating nucleosome structures as epigenetic biomarkers of cancer within the blood. The results from several large ongoing clinical trials in the EU will provide the basis for application for a CE Mark application, the European equivalent of the FDA approval in the U.S. In support of its PMA submission to the FDA, VolitionRx plans to bridge its European trials with trials in the U.S. to evaluate the NuQ® tests with patient populations representative of U.S. ethnicity.
Ongoing clinical trials assessing the effectiveness of VolitionRx's assays include:
Colorectal cancer
A 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark)
A 14,000 patient prospective screening study (Hvidovre Hospital, University of Copenhagen, Denmark)
A 250 patient prospective study (CHU-UCL Mont Godinne Hospital, Belgium)
Pre-cancerous colorectal adenomas
A 800 patient retrospective study (Hvidovre Hospital, University of Copenhagen, Denmark)
27 most prevalent cancers
A 4,200 patient prospective study that involves patients with the 27 most prevalent cancers (University Hospital, Bonn, Germany)
Lung cancer
A 600 patient prospective confirmatory study (University Hospital, Bonn, Germany)
Prostate cancer
A retrospective study to establish the efficacy of VolitionRx's NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form (MD Anderson Cancer Center, Texas)
A 120-patient prospective feasibility study (ImmuneHealth, Belgium)
Ovarian cancer
A 40-patient prospective feasibility study (Singapore General Hospital, Singapore)
Endometriosis
A prospective study to assess VolitionRx's NuQ® tests for the diagnosis of endometriosis (the University of Oxford, United Kingdom)
Deal Flow
3,060,725 Shares of Common Stock
($0.001 par value)
This prospectus supplement supplements information contained in that certain prospectus dated April 25, 2014, as amended, of VolitionRx Limited (the “Company”), relating to
The following amends and supplements the information set forth in the prospectus under the caption “Selling Stockholders” with respect to the Selling Stockholders named below and the respective shares of common stock beneficially owned by such Selling Stockholders that may be offered pursuant to the prospectus:
Name of Selling Stockholder
Position,
Office or Other
Material
Relationship
Shares
Beneficially
Owned Prior to
the Offering
Shares to be
Offered
Shares
Beneficially
Owned After
the Offering
Percentage
Beneficially
Owned after
the Offering
David R. Morgan
25,000
25,000
0
0.00%
Sean Marconi
12,500
12,500
0
0.00%
OTA, LLC(22)
25,000
25,000
0
0.00%
Gael Forterre(23)
74,850
12,500
62,350
*
Comments & Business Outlook
First Quarter 2015 Financial Results
For the three months ended March 31, 2015 , VolitionRx reported a net loss of $2 million , or $0.12 per share. This compares to a net loss of $2.2 million , or $0.18 per share in the first quarter of 2014.
"We have had a tremendously important quarter, significantly advancing our clinical programs in colorectal, pancreatic and lung cancers. Our core, large colorectal cancer trials are progressing smoothly and we expect to announce the next large tranche of data in Q3 2015, while simultaneously leveraging opportunities to maximize the reach of our Nucleosomics® technology in other cancers. The ability to conduct so many large, blinded independent trials simultaneously has been made possible by the commissioning of our first Tecan automated laboratory robot, which became fully operational during Q1, and with the arrival of three new Tecan machines in April. These four Tecan machines will enable us to process as many patient samples in a single month as we have manually processed in the entire 5-year history of our company. This increased throughput is crucial as we process the 18,800 patient samples in our two Danish colorectal trials, and begin to explore the capabilities of our NuQ® platform in 27 cancers in our large clinical trial in Bonn," said Cameron Reynolds , President and Chief Executive Officer of VolitionRx. "The proceeds from our recent public offering are expected to fund the Company into the second half of 2016 in line with our budget. We believe that VolitionRx is well positioned to continue advancing the clinical development of our NuQ® platform and to begin developing a framework for product commercialization as we work to realize the full potential of this revolutionary technology for the early detection of cancer," concluded Mr. Reynolds.
Hot Bio-Tech News
NAMUR , Belgium , May 8, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, today announced that it has accelerated its large independent prospective study evaluating its proprietary Nucleosomics� platform at University Hospital Bonn in Germany . VolitionRx has dedicated two of itsrecently-procured Tecan EVO200 automated laboratory robots to the study, with sample analysis to begin early in the third quarter of 2015. In addition, VolitionRx and study lead Prof. Stefan Holdenrieder at the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn in Germany have increased the sample size and breadth of cancer types being tested.
The study initially included 4,000 patient blood samples across 20 of the most prevalent cancer types, and has now been expanded to include approximately 4,200-patient blood samples across 27 of the most prevalent cancers, including: two types of respiratory cancer, seven types of gastrointestinal cancer, four gynecological cancers, four urinary cancers, four types of hematological cancer, plus melanoma, sarcoma and cancers of the thyroid and brain; as well as control patients with 24 other conditions and healthy individuals. In total, the cancer types being analyzed represent over 95% of the incidence of cancer.
Dr. Jake Micallef , VolitionRx's Chief Scientific Officer, said, "This trial is an incredibly important one, which we hope will show the breadth of our Nucleosomics� technology. The trial is not only essentially 27 pilot studies in the most common cancers, but we are also looking for differences between cancers, and between cancers and other diseases, to discover if a panel of assays can detect several cancers from the same blood draw. We are grateful to Prof. Holdenrieder for his commitment to this ongoing multi-year trial, demonstrated by the increase of sample size and broadening of cancer types being evaluated in the trial � both of which we hope will enable us to more clearly demonstrate accuracy rates of our NuQ� test in these patient populations."
Cameron Reynolds , Chief Executive Officer of VolitionRx, commented, "We are very excited that with the addition of two fully-operational automated robot systems, analysis of the full 4,200 sample collection is on track to begin early in the third quarter of 2015. We expect to analyze the samples with up to 10-15 NuQ� assays by the first quarter of 2016. The aim of the trial is both to evaluate a large number of cancers and to look for a panel of assays that can diagnose multiple cancers for potential new products beyond the current four cancers we are evaluating."
Prof. Stefan Holdenrieder at the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn in Germany , who is leading the study, added, "Collectively, cancer is one of the foremost causes of mortality around the world and there remains a significant global need for improved early cancer detection. An accurate and non-invasive test using only a drop of blood that could detect a range of cancers would provide physicians and patients an opportunity to treat the disease early on, before the cancer metastasizes, providing greater chances of survival. Collection and analysis of samples has been, and will continue to be, carried out in my laboratory with VolitionRx providing the assays for analysis. I am very much looking forward to seeing the results from this study."
The NuQ� tests utilize the Company's proprietary Nucleosomics� technology platform, which identifies and measures circulating nucleosome structures for the presence of epigenetic cancer and signals within the blood.
Clinical trials assessing the effectiveness of VolitionRx's assays include:
Colorectal cancer:
A 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen, Denmark)
A 14,000 patient prospective screening study (Hvidovre Hospital, University of Copenhagen, Denmark)
A 250 patient prospective study (CHU-UCL Mont Godinne Hospital, Belgium )
Pre-cancerous colorectal adenomas:
A 800 patient prospective study (Hvidovre Hospital, University of Copenhagen, Denmark)
27 most prevalent cancers
A 4,200 patient prospective study that involves patients with the 27 most prevalent cancers (University Hospital, Bonn, Germany )
Lung cancer:
A 600 patient prospective confirmatory study (University Hospital, Bonn, Germany )
Prostate cancer:
A retrospective study to establish the efficacy of VolitionRx's NuQ� tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form (MD Anderson Cancer Center, Texas )
A 120 p atient prospective feasibility study (ImmuneHealth, Belgium )
Ovarian cancer:
A 40 p atient prospective feasibility study (Singapore General Hospital, Singapore )
Endometriosis
A prospective study to assess VolitionRx's NuQ� tests for the diagnosis of endometriosis (the University ofOxford, United Kingdom )
Comments & Business Outlook
NAMUR , Belgium , April 9, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, today announced that it has procured three additional Tecan EVO200 automated liquid handling systems (automated laboratory robots) to expedite analysis of samples for the ongoing large clinical trials evaluating its NuQ® cancer detection platform. By increasing capacity to four automated systems, throughput and rate of sample analysis will be greatly increased, enabling faster development of the Company's NuQ® tests.
Cameron Reynolds , Chief Executive Officer of VolitionRx, remarked, "This budgeted investment greatly supports our Company's strategic decision to maximize the speed and efficiency of our ongoing large clinical trials. The use of four automated systems will support the generation of extensive amounts of data and allow for faster study timelines to full data readouts. We expect that this increased data generation capacity will result in more scientific publications, quicker access to CE mark in Europe and an overall accelerated approach to regulatory pathways worldwide."
Using its first installed robot, VolitionRx has recently completed the analysis of a first NuQ® assay on the complete set of 4,800 blood samples for its large retrospective, symptomatic population colorectal cancer study in collaboration with Hvidovre Hospital, University of Copenhagen , Denmark. Procuring three new Tecans allows the Company to dedicate one robot to this study, and VolitionRx now hopes to complete one NuQ® assay per month on the full data set for the 4,800-patient cohort. At this capacity, the Company expects to finalize its analysis and determine an initial NuQ® colorectal cancer panel during the second half of 2015.
Gaetan Michel , PhD, Chief Operations Officer of Belgian Volition, commented, "The fully-dedicated Tecan platform currently allows us to run analysis of approximately 5,000 samples per month per robot. The reproducibility and robustness of these automated assays is extremely encouraging and will allow for optimal output of reliable large scale results. We are currently further optimizing the platform process to reach a 50 percent capacity increase to 7,500 samples per month per robot."
VolitionRx Chief Scientific Officer Dr. Jake Micallef added, "Over the past five years, since VolitionRx was established, we have manually processed approximately 30,000 samples across all our studies, in multiple cancers. Due to the significant increase in the number of clinical studies we now have underway, and our constant development of new biomarkers for new assays, we determined that it was essential to make a step change in our processing capabilities through additional automated platforms. This investment will allow us to reach an impressive capacity of 30,000 assays per month, approximately the same amount as we have completed in total. The first robot is fully up and running and all four are due to be delivered by the end of April and should be fully operational by the end of May."
The NuQ® tests utilize the Company's proprietary Nucleosomics® technology platform, which identifies and measures circulating nucleosome structures for the presence of epigenetic cancer and signals within the blood.
VolitionRx has developed a suite of NuQ® assays for more than 20 different epigenetic structures on nucleosomes. These assays use two antibodies. The first antibody is attached to a plastic surface and binds to nucleosomes. The second antibody is chemically detectable and binds to the epigenetic structure of interest contained within the nucleosome. When blood is added to the antibody-coated plastic plate, nucleosomes in the blood bind to the first antibody. The second antibody is then added and can only be chemically detected if nucleosomes containing the epigenetic structure of interest are present. The NuQ® assay uses less than a single drop of blood to measure nucleosomes that contain the epigenetic structure of interest and the level of these nucleosomes is different in the blood of cancer patients than in healthy people. Each NuQ® cancer test uses a combination of 4-5 of these proprietary assays to form a "panel" test.
Clinical trials assessing the effectiveness of VolitionRx's assays include:
Colorectal cancer:
A 4,800 patient retrospective symptomatic population study (Hvidovre Hospital, University of Copenhagen , Denmark)
A 14,000 patient prospective screening study (Hvidovre Hospital, University of Copenhagen , Denmark)
A 250 patient prospective study (CHU-UCL Mont Godinne Hospital, Belgium )
Lung cancer:
A 600 patient prospective confirmatory study (University Hospital, Bonn, Germany )
Prostate cancer:
A retrospective study to establish the efficacy of VolitionRx's NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form (MD Anderson, Texas )
A 120-patient prospective feasibility study (ImmuneHealth, Belgium )
Ovarian cancer:
A 40-patient prospective feasibility study (Singapore General Hospital, Singapore )
20 most prevalent cancers
A 4,000 patient prospective study that involves patients with the 20 most prevalent cancers at University Hospital in Bonn, Germany
Endometriosis
A prospective study to assess VolitionRx's NuQ® tests for the diagnosis of endometriosis (the University of Oxford, United Kingdom )
Comments & Business Outlook
VOLITIONRX LIMITED
Consolidated Statements of Operations and Comprehensive Loss
(Expressed in US dollars)
For the year ended December 31, 2014
$
For the year ended December 31, 2013
$
Revenue
14,785
-
Expenses
General and administrative
299,051
434,006
Professional fees
533,716
621,722
Salaries and office administrative fees
1,075,410
666,419
Research and development
4,044,023
2,503,765
Impairment of patents
-
350,000
Total Operating Expenses
5,952,200
4,575,912
Net Operating Loss
(5,937,415)
(4,575,912)
Other Income/(Expenses)
Grants received
143,987
865,623
Loss on derivative liabilities
(2,420,101)
-
Net Other Income/ (Expenses)
(2,276,114)
865,623
Provision for Income Taxes
-
-
Net Loss
(8,213,529)
(3,710,289)
Other Comprehensive Loss
-
-
Foreign currency translation adjustments
(44,037)
(25,519)
Total Other Comprehensive Loss
(44,037)
(25,519)
Net Comprehensive Loss
(8,257,566)
(3,735,808)
Net Loss per Share–Basic and Diluted
(0.61)
(0.34)
Weighted Average Shares Outstanding–Basic and Diluted
13,435,253
10,832,369
Management Discussion and Analysis
Revenues
The Company had revenues of $14,785 from operations in the year ended December 31, 2014, compared to no revenues in the comparative period for the year ended December 31, 2013. The Company’s operations are still predominantly in the development stage.
For the year ended December 31, 2014, our net loss was $8,213,529, an increase of $4,503,240 or 121% over the comparative period for the year ended December 31, 2013. The change is a result of the changes described above.
Hot Bio-Tech News
Study in collaboration with Belgium-based CRO, ImmuneHealth
NAMUR , Belgium , March 5, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, today announced that it has initiated a pilot study to assess the feasibility of VolitionRx's proprietary NuQ® assays in detecting prostate cancer. The study is in collaboration with ImmuneHealth, a global biomarker contract research organization (CRO), and is taking place in Belgium .
In the prospective study, 120 blood samples will be collected from patients across four Belgian hospitals and analyzed by Belgium -based ImmuneHealth using VolitionRx's NuQ® assays, which are based on the Company's proprietary Nucleosomics® technology. Four groups of patients will be assessed: aggressive prostate cancer, indolent prostate cancer, prostate hyperplasia and negative controls. In addition to determining the test's ability to accurately detect prostate cancer, the study will also assess the tests' ability to distinguish among the different prostate conditions and healthy samples. If the test demonstrates significant accuracy, it could have the potential to become an early-stage screening tool.
VolitionRx Chief Scientific Officer Dr. Jake Micallef commented, "In addition to our anaplastic prostate cancer study in collaboration with MD Anderson , we are now embarking on a pilot diagnostic prostate cancer study with ImmuneHealth of Belgium . While the anaplastic study is aimed at the differential detection of this particularly aggressive form of prostate cancer requiring very aggressive treatment, the ImmuneHealth study will investigate our NuQ® assays for more general prostate cancer detection. Both early prostate cancer detection and selection of patients for aggressive treatment are critical for improved outcomes, which is why we are launching a second study with ImmuneHealth to further evaluate our NuQ® assays in this indication. In addition, we are grateful to the Walloon region of Belgium which is covering the majority of the costs of the study."
ImmuneHealth Business and Marketing Director Julien Isoard remarked, "As a global CRO specializing in the clinical support for biomarker panels development, we are committed to facilitating the generation of clinically meaningful data and samples through quality patient cohorts that companies like VolitionRx can use to demonstrate their diagnostics' ability to benefit patients and physicians. Based on the analysis we will conduct, it is our hope that VolitionRx's NuQ® tests are further evaluated in larger studies that will enable the Company to bring to market a simple, non-invasive and cost-effective blood test to better diagnose patients with prostate cancer."
The NuQ® tests utilize the Company's proprietary Nucleosomics® platform, which identifies and measures circulating nucleosome structures for the presence of epigenetic cancer and signals within the blood.
In addition to this prostate cancer study, other clinical trials assessing the effectiveness of VolitionRx's assays include:
A 4,800 patient retrospective symptomatic population study in colorectal cancer at Hvidovre Hospital, University of Copenhagen , Denmark
A 14,000 patient prospective screening study in colorectal cancer at Hvidovre Hospital, University of Copenhagen , Denmark
A 4,000 patient prospective study that involves patients with the 20 most prevalent cancers at University Hospital in Bonn, Germany
A 600 patient prospective confirmatory study in lung cancer at University Hospital in Bonn, Germany
A 250 patient prospective study in colorectal cancer at CHU-UCL Mont Godinne Hospital, Belgium
A retrospective study with MD Anderson, Texas , to establish the efficacy of VolitionRx's NuQ® tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form.
A prospective study with the University of Oxford, United Kingdom , to assess VolitionRx's NuQ® tests for the diagnosis of endometriosis.
A 40 patient prospective study with Singapore General Hospital (SGH) to establish the feasibility of VolitionRx's proprietary NuQ® assays in detecting ovarian cancer.
Notable Share Transactions
NAMUR , Belgium , February 17, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, today announced that the underwriters of its previously announced offering of common stock have exercised the option to purchase an additional 343,383 shares at a price of $3.75 per share.
Deal Flow
Common Stock
We are offering 2,475,000 shares of our common stock pursuant to this prospectus.
Our common stock is currently quoted on the OTCQB under the symbol “VNRX”. On February 5, 2015, the closing price of our common stock was $4.10 per share.
Our common stock has been approved for listing on the NYSE MKT under the symbol “VNRX”.
Per Share
Total
Public offering price
$
3.75
$
9,281,250
Underwriting discount(1)
$
0.30
$
742,500
Proceeds to us, before expenses
$
3.45
$
8,538,750
Deal Flow
NAMUR, Belgium, Feb. 6, 2015 /PRNewswire / -- VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, today announced the pricing of its public offering of 2,475,000 shares of its common stock, at an offering price of $3.75 per share. In addition, VolitionRx has granted the underwriters a 30-day over-allotment option to purchase up to 371,250 additional shares of common stock at the public offering price. All of the shares are being offered by the Company. The shares of VolitionRx are expected to begin trading on the NYSE MKT under the symbol "VNRX" on February 6, 2015.
National Securities Corporation, a wholly owned subsidiary of National Holdings Corporation (OTCBB:NHLD) and Lake Street Capital Markets are acting as joint book running managers for the offering. The Benchmark Company is acting as co-manager for the offering.
The Company expects net proceeds from the offering, excluding the exercise of the over-allotment option, if any, to be approximately $8.5 million, after deducting underwriting discounts and commissions and other offering-related expenses. VolitionRx intends to use the proceeds of this offering to fund prospective colorectal trials with Hvidovre Hospital in Denmark and an ongoing study at University Hospital in Bonn, Germany, as well as for general working capital and other corporate purposes.
In conjunction with its listing on the NYSE MKT, VolitionRx's shares of common stock will cease quotation on the OTCQB.
The offering is expected to close on February 11, 2015, subject to customary closing conditions.
Deal Flow
CALCULATION OF REGISTRATION FEE
Title of Each Class of Securities to be Registered
Proposed Maximum Aggregate Offering Price(1)
Amount of Registration Fee(2)
Common stock, $0.001 par value
$
11,500,000.00
$
1,336.30(3)
Deal Flow
CALCULATION OF REGISTRATION FEE
Title of Each Class of Securities to be Registered
Proposed Maximum Aggregate Offering Price(1)
Amount of Registration Fee(2)
Common stock, $0.001 par value
$
11,500,000.00
$
1,336.30(3)
Hot Bio-Tech News
NAMUR, Belgium, January 7, 2015 /PRNewswire / -- VolitionRx Limited (OTCQB: VNRX), a life sciences company focused on developing diagnostic tests for cancer and other conditions, today announced that it has completed a blinded clinical study demonstrating that its NuQ� blood-based diagnostic platform is able to accurately detect 84% of early, surgically-treatable pancreatic cancers at high 92% specificity. The blinded study was conducted in collaboration with Lund University, Sweden and led by Roland Andersson, MD, PhD, Professor of Surgery and Vice-Dean, Faculty of Medicine.
VolitionRx Chief Executive Officer Cameron Reynolds, said, "Pancreatic cancer is the fourth leading cause of cancer deaths in the developed world and its incidence is rising.[i] Unfortunately, it is often described as a 'silent killer' with a high mortality rate and 5-year survival rate of approximately 6%,[i] which is largely due to a lack of early-stage detection capabilities. With the development of this blood test, we hope to improve the prognosis for pancreatic cancer patients by detecting the disease before it reaches an advanced state."
In the 60-patient study, blood samples were taken from 25 subjects with stage IIa or stage IIb pancreatic cancer as well as 25 healthy subjects and 10 subjects with other pancreatic diseases including chronic pancreatitis, intraductal papillary mucinous neoplasm (IPMN; a pre-cancerous condition which may lead to pancreatic cancer), serous cystadenoma (a benign tumor) and tubular adenoma in papilla vateri (another type of benign tumor).
Analysis of the blood samples demonstrated that a panel of five NuQ� assays distinguished 21 of the 25 pancreatic cancer cases from healthy subjects (84% sensitivity), with only two false positive results among the 25 healthy subjects (92% specificity).
Furthermore, the same panel of NuQ� assays was able to distinguish 19 of the pancreatic cancer cases (76% sensitivity) from all other subjects including healthy subjects and those with other pancreatic diseases with only a single false positive for one healthy subject and two false positives for subjects with other pancreatic diseases, one of which was a subject with pre-cancerous IPMN condition(91% specificity).
Dr. Roland Andersson, MD, PhD, Professor of Surgery Vice Dean, Faculty of Medicine Lund University, Sweden, remarked, "In my opinion there are currently no good diagnostic tests for the early detection of pancreatic cancer, so an 84% rate of detection using a simple blood draw is an exciting result, which, in addition to the further ability to differentiate pancreatic cancer from other pancreatic diseases, demonstrates the potential of a test to save many lives and become a significant medical advancement. VolitionRx appears to have a unique platform technology through its IP in circulating nucleosomes. These results are very encouraging and we look forward to confirming the findings in further, larger studies in collaboration with VolitionRx."
VolitionRx Chief Scientific Officer Dr. Jake Micallef commented, "These early data for NuQ� assays in pancreatic cancer show excellent clinical accuracy which may be improved further if used in conjunction with established CA19-9 ELISA tests. Nucleosomics� has been found to be effective for the detection of colorectal cancer as well as pre-cancerous colorectal polyps, prostate cancer, lung cancer and now, pancreatic cancer. Moreover, there is evidence that NuQ� tests can also distinguish these cancers from each other. We will continue with further clinical studies to demonstrate the clinical utility of our Nucleosomics� technology in the detection of cancers and are excited to advance the pancreatic cancer test into larger studies that we hope will confirm these promising results."
The NuQ� tests utilize the Company's proprietary Nucleosomics� platform, which identifies and measures circulating nucleosome structures for the presence of epigenetic cancer and signals within the blood.
In addition to the pancreatic cancer study, other clinical trials assessing the effectiveness of VolitionRx's assays include:
A 4,800 patient retrospective symptomatic population study in colorectal cancer at Hvidovre Hospital, University of Copenhagen, Denmark
A 14,000 patient prospective screening study in colorectal cancer at Hvidovre Hospital, University of Copenhagen, Denmark
A 4,000 patient prospective study that involves patients with the 20 most prevalent cancers at University Hospital in Bonn, Germany
A 600 patient prospective confirmatory study in lung cancer at University Hospital in Bonn, Germany
A 250 patient prospective study in colorectal cancer at CHU-UCL Mont Godinne Hospital, Belgium
A retrospective study with MD Anderson, Texas, to establish the efficacy of VolitionRx's NuQ� tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form.
A prospective study with the University of Oxford, United Kingdom, to assess VolitionRx's NuQ� tests for the diagnosis of endometriosis.
Deal Flow
CALCULATION OF REGISTRATION FEE
Title of Each Class of Securities to be Registered
Proposed Maximum Aggregate Offering Price(1)
Amount of Registration Fee(2)
Common stock, $0.001 par value
$
11,500,000.00
$
1,336.30
Hot Bio-Tech News
NAMUR , Belgium , Nov. 11, 2014 /PRNewswire / -- VolitionRx Limited (OTCQB: VNRX), a life sciences company focused on developing blood-based diagnostic tests, today announced that it has entered an agreement with the University of Oxford, United Kingdom , to initiate a clinical study that will assess VolitionRx's proprietary Nucleosomics� platform technology for the diagnosis of endometriosis through a simple blood test. Under the agreement, The University of Oxford will provide VolitionRx with serum and plasma samples from approximately 350 patients with endometriosis and 150 control patients over a period of two years. The samples are donated by participating women through the biospecimen repository of the Oxford Endometriosis CaRe Centre.
Endometriosis is a common and painful condition in which endometrial tissue, which normally lines the cavity of the uterus, grows in other parts of the body[1]. It is a benign condition with a strong inflammatory component, which makes the disease a good candidate for Volition's NuQ� assays. The condition mostly affects women during their reproductive life span, and is a leading cause of difficulty conceiving. Unfortunately, there are currently no clinically useful biomarkers available for this condition, meaning diagnosis is only possible by performing minimally invasive surgery (laparoscopy). Across the world, this typically results in a delay in diagnosis of nearly 7 years[2].
The prospective study will focus on the development of a simple blood test to help clinicians diagnose endometriosis at an earlier stage. The 350-patient sample collection, supplemented with approximately 150 retrospectively-collected samples, will comprise healthy and endometriosis-positive individuals confirmed by laparoscopy. Differences in circulating nucleosomes will be evaluated across the menstrual cycle using VolitionRx's Nucleosomics� technology platform.
Collection of the samples will be led by Prof Christian Becker and Prof Krina Zondervan , of the Nuffield Department of Obstetrics & Gynaecology, University of Oxford, who are co-Directors of the Endometriosis CaRe Centre, Oxford . The Centre is a world leader in endometriosis research and clinical care and is dedicated to improve the life of women affected by the disease. The study will assess the samples collected from patients undergoing laparoscopic surgery for endometriosis-related symptoms or patients undergoing laparoscopic tubal sterilisation. Sample collection is anticipated to end in 2016 as part of an ongoing biospecimen collection and biobanking program.
"We are excited to sign this agreement with the University of Oxford," commented Dr. Mark Eccleston , VolitionRx's Collaborations Manager. "We look forward to assessing the potential of our test in the diagnosis of endometriosis and to build on our ongoing work in cancer screening by exploring applications of our NuQ� assays in diseases beyond cancer."
Prof Becker said: "We are looking forward to the results of this study. It compliments our ongoing efforts in the Endometriosis CaRe Centre of identifying non-invasive biomarkers for endometriosis which will be an essential step towards improved patient care."
In addition to this study, other clinical trials assessing the effectiveness of VolitionRx's assays include:
A 4,800 patient retrospective study and an 14,000 patient prospective study in colorectal cancer at Hvidovre Hospital, University of Copenhagen, Denmark
A 4,000 patient prospective study that involves patients with the 20 most prevalent cancers at University Hospital in Bonn, Germany
A 250 patient study in colorectal cancer at CHU-UCL Mont Godinne Hospital, Belgium
A study with MD Anderson, Texas , to establish the efficacy of VolitionRx's NuQ� tests to distinguish anaplastic prostate cancer, a particularly aggressive form of the disease, from typical castration resistant prostate cancer (CRPC), the less aggressive form.
Comments & Business Outlook
VOLITIONRX LIMITED
(A Development Stage Company)
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Expressed in US dollars)
(unaudited)
For the three months ended September 30, 2014
For the three months ended September 30, 2013
For the nine months ended September 30, 2014
For the nine months ended September 30, 2013
$
$
$
$
Revenue
14,785
–
14,785
–
Expenses
General and administrative
129,318
67,961
249,986
242,660
Professional fees
119,510
153,226
412,532
310,585
Salaries and office administrative fees
457,355
179,846
670,518
569,238
Research and development
1,071,984
524,534
2,733,742
1,758,372
Total Operating Expenses
1,778,167
925,567
4,066,778
2,880,855
Net Operating Loss
(1,763,382)
(925,567)
(4,051,993)
(2,880,855)
Other Income/(Expenses)
Grants received
–
–
143,987
–
Loss on derivative remeasurement
(4,130,562)
–
(3,363,561)
–
Net Other Expenses
(4,130,562)
–
(3,219,574)
–
Provision for income taxes
–
–
–
–
Net Loss
(5,893,944)
(925,567)
(7,271,567)
(2,880,855)
Other Comprehensive Loss
Foreign currency translation adjustments
(19,893)
(6,478)
(33,731)
(18,336)
Total Other Comprehensive Loss
(19,893)
(6,478)
(33,731)
(18,336)
Net Comprehensive Loss
(5,913,837)
(932,045)
(7,305,298)
(2,899,191)
Net Loss per Share – Basic and Diluted
(0.44)
(0.08)
(0.56)
(0.27)
Weighted Average Shares Outstanding – Basic and Diluted
13,524,998
11,086,237
13,057,866
10,649,152
Management Discusson and Analysis
Revenues
The Company had revenues of $14,785 from operations in the three months ended September 30, 2014, and no revenues from operations in the comparative period for the three months ended September 30, 2013. The Company’s operations are still predominantly in the development stage.
For the three months ended September 30, 2014, the Company recorded a net loss of $5,893,944, a negative change of $4,968,377 or 536.8% in relation to the comparative period loss of $925,567 for the three months ended September 30, 2013. The change is a result of the changes described above.
Hot Bio-Tech News
NAMUR, Belgium, Sept. 11, 2014 /PRNewswire / -- VolitionRx Limited (VNRX), a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types, today announced that CEO Cameron Reynolds will this morning present topline data from its 4,800-subject colorectal cancer trial at Hvidovre Hospital, Copenhagen, Denmark. Mr. Reynolds will present data from an initial representative 938-subject sample, demonstrating that the Company is able to correctly diagnose 84% of colorectal cancers, including early-stage cancers, using its NuQ� blood-based diagnostic platform.
Mr. Reynolds will discuss the data during a presentation at the 2014 Aegis Capital Healthcare & Technology Conference today at 9:00 a.m. U.S. Pacific Time. Mr. Reynolds' presentation will be available from today on the Company's website at www.volitionrx.com.
Despite the existence of screening programs for the disease, colorectal cancer remains the second leading cause of cancer-related death in the U.S.[i] , partly due to the cost, and to low compliance with colonoscopies and other screening methods like fecal tests. Furthermore, colorectal cancer is often found after symptoms appear, which typically only happens with more advanced disease[i]. However, colorectal cancer is one of the more survivable diseases if caught early: it has an observed five-year survival rate of 74% in stage I, but only 6% in stage IV[i]. Put simply, many lives could be saved if colorectal cancer were caught earlier. VolitionRx's NuQ� test aims to meet this need by detecting colorectal cancer through a simple, accurate, cost-effective, blood test.
Analysis of the 938-subject sample of the study demonstrated that the NuQ� diagnostic test detected 84 percent of colorectal cancers at 78% specificity, and 60 percent of polyps, in a population aged over 50 years with symptoms indicative of colorectal cancer. The NuQ� test used to achieve these results was a panel of three individual NuQ� assays, each of which identifies and measures a separate nucleosome structure in the blood. Each NuQ� panel used a small amount of blood - only 60�L or about a drop per subject. Data showed that the NuQ� test is able to detect early stage (I or II) disease and late-stage (III or IV) disease with similar accuracy, allowing for earlier detection and treatment of colorectal cancer and enabling the potential for improved patient outcomes.
Dr. Jake Micallef, Chief Scientific Officer of VolitionRx, commented, "VolitionRx has shown similar results previously in smaller colorectal cancer studies but confirmation that NuQ� tests are effective in a large, blind study is a landmark result for us. Moreover, the Nucleosomics� technology is not limited to the three assays used in this study, but incorporates hundreds of potential epigenetic NuQ� tests that may have applicability in colorectal and other cancers. We will share further analysis of the results from these 938 subjects at the 9th International Conference of Anticancer Research in October this year."
Professor Hans Jo rgen Nielsen, Professor of Surgical Oncology at Hvidovre Hospital in Denmark, remarked, "This is an extremely promising result in a symptomatic population. Collection has now begun for a much larger 14,000-subject screening study in Denmark, and we expect to begin delivering the first several thousand samples to VolitionRx for analysis in the early part of 2015."
Cameron Reynolds, Chief Executive Officer of VolitionRx Limited, commented, "An accurate, early, and cost effective blood test to screen for colorectal cancer would mark a revolutionary advancement in the way we test for and diagnose this terrible disease. These exciting results from our latest analysis, which demonstrated 84% accuracy in colorectal cancer detection, confirm that the NuQ� test enables accurate early identification of colorectal cancer through a simple blood test."
VolitionRx has today closed a fund raise of $1.127 million. The raise consists of 512,614 shares at $2.20 (including insider conversions of $46,748). Monies raised will go towards VolitionRx's ongoing operations and clinical trials.
Hot Bio-Tech News
NAMUR, Belgium, August 13, 2014 /PRNewswire / -- VolitionRx Limited (OTCQB: VNRX), a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, today announced it has installed a Tecan EVO200 automated liquid handling system in its Namur, Belgium laboratory. The Tecan EVO200 is a robot that will significantly accelerate VolitionRx's large scale clinical studies by increasing the throughput and rate of blood sample analysis by up to five times that of the current manual methods. Initially the robot will be used in a stand-alone mode but Volition is in the process of establishing a Laboratory Information Management System (LIMS) which will integrate the robot into a wider laboratory automation system. This will provide a seamless workflow incorporating blood sample recognition, testing, data capture, and quality control as part of a quality management system.
VolitionRx also recently outsourced large-scale production of their NuQ® kits to complement the increased sample processing capabilities the EVO200 system brings. Outsourced kit production and implementation of the quality system will be overseen by newly appointed Chief Operations Officer, Gaetan Michel, who joined the company on 1st July. These are key milestones in moving towards European CE market approval and the ramp up for the release of our kits into the clinical market.
Installation of the robot is particularly significant as the company today announced an increase of 3,000 (from 11,000 to 14,000) in the number of prospective blood samples to be included in its on-going colorectal cancer clinical trial, which is jointly sponsored by VolitionRx and the University of Copenhagen. The study is designed to evaluate the validity of VolitionRx's proprietary NuQ® panel as a first-step screening tool for colorectal cancer and has been expanded by 42% since it initially commenced. The additional blood samples are being collected by Professor Hans Jorgen Nielsen, Professor of Surgical Oncology at the Department of Surgical Gastroenterology at Hvidovre Hospital, part of the University of Copenhagen, and collaborators at seven additional Danish hospital departments.
Speaking about today's announcements, Cameron Reynolds, CEO of VolitionRx, commented, "This is an exciting time for Volition with lots of positive change as we move towards regulatory approval and clinical launch of our products. The automated sample testing technology we have invested in will speed up our workflow and the extension to our trial with Hvidovre Hospital will give us the opportunity to analyse further data in relation to colonoscopy findings. The next key milestone will be the release of the first data from our pivotal Danish trials at the Aegis Capital Corp. 2014 Healthcare & Technology conference, to be held 10th September to 13th in Las Vegas, NV."
Other clinical trials assessing the effectiveness of Volition's assays include:
A 4,000 patient prospective study that involves patients with the 20 most prevalent cancers at University Hospital in Bonn, Germany
A 250 patient study into colorectal cancer at CHU-UCL Mont Godinne Hospital, Belgium
Comments & Business Outlook
VOLITIONRX LIMITED
(A Development Stage Company)
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Expressed in US dollars)
(unaudited)
For the three months ended
June 30,
2014
$
For the three months ended
June 30,
2013
$
For the six months ended
June 30,
2014
$
For the six months ended
June 30,
2013
$
For the period from
August 5, 2010
(Date of Inception) to June 30,
2014
$
Revenue
–
–
–
–
54,968
Expenses
General and administrative
51,757
123,143
120,668
174,699
1,269,896
Professional fees
165,901
92,394
293,022
157,359
1,929,576
Salaries and office administrative fees
41,485
191,315
213,163
389,392
2,323,757
Research and development
791,294
640,639
1,661,758
1,233,838
8,631,895
Impairment of patents
–
–
–
–
350,000
Total Operating Expenses
1,050,437
1,047,491
2,288,611
1,955,288
14,505,124
Net Operating Loss
(1,050,437)
(1,047,491)
(2,288,611)
(1,955,288)
(14,450,156)
Other Income
Grants received
–
–
143,987
–
1,009,610
Gain on derivative remeasurement
1,867,241
–
767,001
–
767,001
Other Income
1,867,241
–
910,988
–
1,776,611
Provision for income taxes
–
–
–
–
–
Net Income (Loss)
816,804
(1,047,491)
(1,377,623)
(1,955,288)
(12,673,545)
Other Comprehensive Loss
Foreign currency translation adjustments
(9,642)
(12,871)
(13,838)
(11,858)
(73,633)
Total Other Comprehensive Loss
(9,642)
(12,871)
(13,838)
(11,858)
(73,633)
Net Comprehensive Income (Loss)
807,162
(1,060,362)
(1,391,461)
(1,967,146)
(12,747,178)
Net Income (Loss) per Share – Basic
0.06
(0.10)
(0.11)
(0.19)
– Diluted
0.06
(0.10)
(0.11)
(0.19)
Weighted Average Shares Outstanding
– Basic
13,388,050
10,642,175
12,821,421
10,427,414
– Diluted
13,887,997
10,642,175
12,821,421
10,427,414
Management Discussion and Analysis
Revenues
The Company had no revenues from operations in the three months ended June 30, 2014, and no revenues from operations in the comparative period for the three months ended June 30, 2013. The Company’s operations are in the development stage.
For the three months ended June 30, 2014, our net income was $816,804, a change of $1,864,295 or 178% in relation to the comparative period loss of $1,047,491 for the three months ended June 30, 2013. The change is a result of the changes described above.
CFO Trail
ITEM 5.02. DEPARTURE OF DIRECTORS OR CERTAIN OFFICERS; ELECTION OF DIRECTORS; APPOINTMENT OF CERTAIN OFFICERS.
resigned from his positions as Chief Financial Officer and Treasurer of VolitionRX Limited , a Delaware corporation (the “Company”). Mr. Lewin’s resignation as Chief Financial Officer and Treasurer of the Company did not involve any disagreement with the Company on any matter relating to the Company's operations, policies, practices, or otherwise.
On July 1, 2014, Mike O’Connell (“Mr. O’Connell”) was appointed as Chief Financial Officer and Treasurer of the Company to serve until his successor is duly appointed. On July 1, 2014, Mr. O’Connell accepted such appointment.
MIKE O’CONNELL. Mr. Mike O’Connell is a qualified chartered accountant having trained with Ernst & Young in London. Mr. O’Connell started to work in the field of growing technology companies when he became CFO of the UK based systems integrator Pacific Group Plc (“Pacific”). After the successful sale of Pacific, Mr. O’Connell set up his own consultancy to support investors and fast growing technology businesses – Isosceles Finance Limited (“Isosceles”), by providing finance and accounting infrastructure, CFO and corporate advisory services. Isosceles works with some of the fastest growing businesses in the UK and North America such as Metapack and InsightSoftware.com as well as with publicly quoted businesses such as Digital Barriers Plc and Nomad Digital Plc in the UK. Mr. O’Connell was appointed to serve a Chief Financial Officer and Treasurer because of his extensive financial and accounting knowledge.
Deal Flow
CALCULATION OF REGISTRATION FEE(1)
Title of Each Class
of Securities to beRegistered (1)
Amount to be
Registered
(2)
Proposed Maximum Offering Price Per Share
Proposed Maximum Aggregate Offering Price
Amount of
Registration
Fee
Common stock, $0.001 par value
1,500,000
$
2.68 (3)
$
4,020,000
$
517.78
Common stock, $0.001 par value per share, issuable upon exercise of Investor Warrants
1,500,000
$
2.68 (4)
$
4,020,000
$
517.78
Common stock, $0.001 par value per share, issuable upon exercise of Placement Warrants
30,975
$
2.68 (4)
$
83,013
$
10.69
Common stock, $0.001 par value per share, issuable upon exercise of GVC Warrants
29,750
$
2.68 (4)
$
79,730
$
10.27
Total
3,060,725
$
2.68
$
8,202,743
$
1,056.51
Comments & Business Outlook
VOLITIONRX LIMITED
(A Development Stage Company)
Consolidated Statements of Operations and Comprehensive Loss
(Expressed in US dollars)
For the year ended
December 31,
2013
$
For the year ended
December 31,
2012
$
For the period from
August 5, 2010
(Date of Inception) to December 31,
2013
$
Revenue
-
54,968
54,968
Expenses
General and administrative
434,006
448,037
1,149,228
Professional fees
621,722
250,466
1,636,554
Salaries and office administrative fees
666,419
666,373
2,110,594
Research and development
2,503,765
2,773,142
6,970,137
Impairment of patents
350,000
-
350,000
Total Operating Expenses
4,575,912
4,138,018
12,216,513
Net Operating Loss
(4,575,912)
(4,083,050)
(12,161,545)
Other Income – Grants received
865,623
-
865,623
Provision for income taxes
-
-
-
Net Loss
(3,710,289)
(4,083,050)
(11,295,922)
Other Comprehensive Loss
Foreign currency translation adjustments
(25,519)
(38,914)
(59,795)
Total Other Comprehensive Loss
(25,519)
(38,914)
(59,795)
Net Comprehensive Loss
(3,735,808)
(4,121,964)
(11,355,717)
Net Loss per Share – Basic and Diluted
(0.34)
(0.44)
Weighted Average Shares Outstanding – Basic and Diluted
10,832,369
9,359,934
Management Discussion and Anlaysis
Results of Operations
Revenues
The Company had no revenues from operations in the year ended December 31, 2013, compared to revenues of $54,968 in the comparative period for the year ended December 31, 2012. The Company’s operations are in the development stage.
For the year ended December 31, 2013, our net loss was $3,710,289, a decrease of $372,761 or 9% over the comparative period for the year ended December 31, 2012. The change is a result of the changes described above.
Deal Flow
NAMUR, BELGIUM--(Marketwired - Feb 28, 2014) - VolitionRx Limited (OTCQB : VNRX), a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, today announced the completion of a private placement to selected existing and new accredited investors of 1.5 million shares of common stock at a price of $2.00 per share, as well as five-year warrants to purchase up to an additional 1.5 million shares of common stock at an exercise price of $2.20 per share, which resulted in gross proceeds to VolitionRx of $3 million . Lake Street Capital Markets, LLC acted as exclusive US placement agent on this transaction.
Cameron Reynolds, CEO of VolitionRx, says: "Proceeds from this raise will be used to fund operating costs, including VolitionRx's ongoing clinical trials program, notably our 4,800-individual colorectal cancer trial, for which analysis commenced in January. We plan to use data from the trial in the initial application for European regulatory approval for our first cancer diagnostic test, which will be for colorectal cancer."
The private placement was made only to accredited investors in accordance with Section 4(2) under the Securities Act of 1933, as amended (the "Securities Act"), and the rules and regulations promulgated thereunder. The securities sold in the private placement have not been registered under the Securities Act of 1933 or any state securities laws and unless so registered may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act of 1933 and applicable state securities laws. In connection with the private placement, VolitionRx has agreed, subject to certain terms and conditions, to file a registration statement to register for resale of the common stock issued in the private placement (including the shares issuable upon exercise of the warrants). This announcement is neither an offer to sell nor a solicitation of an offer to buy any of the securities issued in the private placement and is being issued under Rule 135c under the Securities Act.
Hot Bio-Tech News
NAMUR , Belgium , Nov. 14, 2013 /PRNewswire / -- VolitionRx Limited (VNRX:OB), a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, today announced an increase of 55% (from 6,000 to 11,000) in the number of prospective blood samples to be included in its forthcoming colorectal cancer clinical trial at no additional cost beyond the $1.85 million already announced. The randomised, blinded study is designed to evaluate the validity of VolitionRx's proprietary NuQ� panel as a first-step screening tool for colorectal cancer.
Sample collection for this prospective study, which is jointly sponsored by VolitionRx and the University of Copenhagen, is due to commence in April 2014 and be completed by the end of 2015. With the additional blood samples, 8,000 individuals receiving a positive faecal immunological testing (FIT) result and 3,000 individuals receiving a negative FIT result as part of the Danish national screening programme will now be tested using Volition's NuQ assay panel. The results will be verified by colonoscopy. Notably, the Danish team is collecting up to 120 data points for each individual included in the trial (e.g. age, gender, other diseases). This will provide an extremely powerful tool in understanding how different diseases and conditions interrelate with colorectal cancer.
The additional blood samples will be collected by Professor Hans Jorgen Nielsen , Professor of Surgical Oncology at the Department of Surgical Gastroenterology at Hvidovre Hospital, part of the University of Copenhagen, and collaborators at 7 additional Danish hospital departments.
Speaking about the expansion, Professor Nielsen says: "Our decision to provide Volition with these extra samples was driven by the promising interim data from other NuQ trials. This expansion is significant as we will be able to make even stronger conclusions about both the accuracy of VolitionRx's NuQ blood test and the risk factors of colorectal cancer. We also now have the possibility to re-confirm the results of symptom-free individuals who are undergoing screening."
Dr Jake Micallef , Chief Scientific Officer of VolitionRx, adds: "Professor Nielsen and collaborators' collection of extensive blood samples provides the opportunity to identify and validate other molecules and genetic components associated with the growth, invasion and dissemination processes of colorectal cancer. We will now have further data to analyse in relation to colonoscopy findings, to demonstrate the performance of a simple NuQ blood test to diagnose colorectal cancer at an early stage in a non-invasive way. The 11,000 prospective samples are in addition to the already collected 4,800 retrospective symptomatic samples for a combined 16,000 individuals. We have received the first 1,000 samples from the retrospective trial we are carrying out in conjunction with Hvidovre Hospital, and will begin the analysis this year."
In addition to analysing the 16,000 Danish individuals, Volition is carrying out the following trials:
3 ongoing multi-cancer studies at University Hospital in Bonn, Germany , including an 800 patient retrospective study and a 2,000 patient prospective study that involves patients with the 20 most prevalent cancers
a 250 patient study into colorectal cancer at CHU-UCL Mont Godinne Hospital, Belgium .
Data from these trials will be used to apply for a CE mark for a colorectal cancer test, and will also be submitted to the FDA.
Colorectal cancer is the third most prevalent cancer worldwide, after lung and breast cancers, with approximately 1.24 million new cases diagnosed each year. In the United States alone, 136,717 people were diagnosed with colorectal cancer in 2009, with 51,848 dying from the disease that year.
Comments & Business Outlook
NAMUR , Belgium , Sept. 3, 2013 /PRNewswire / -- VolitionRx Limited (OTC: VNRX), a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, is lead partner of a consortium in a project valued at �779,493 (approx.US$1M) under the EUREKA Eurostars scheme. The project aims to develop new applications of the Nucleosomics biomarker technology in inflammatory disease. The research will build on VolitionRx's ongoing cancer diagnostic research program.
VolitionRx's contribution to the project is to develop novel NuQ� biomarkers for immune response. VolitionRx will use its proprietary Nucleosomics� platform for biomarker development exploiting UK-based Alcyomics' proprietary ex-vivo Skimmune� model.
The Eurostars Programme is a European innovation program managed by EUREKA. It is the first program dedicated to supporting research-based small- and medium-sized companies (SMEs) from across Europe . To be eligible for the grant, companies must form a consortium of at least two companies from different European countries, with the aim of developing a civilian-purposed new product, process or service.
"The Eurostars scheme is a prestigious European program designed to support SMEs like VolitionRx, and to encourage cross-border research and development collaboration," says Mark Eccleston , VolitionRx's External Collaborations Manager. "We are looking forward to working with our partners to develop novel applications for our Nucleosomics technology, while complementing our ongoing research in cancer diagnostics."
Under the grant, VolitionRx will be reimbursed with 80% of the costs associated with its share of the joint project - �420,000 ($0.56M approx.) over two years.
Comments & Business Outlook
NAMUR , Belgium , April 4, 2013 /PRNewswire / -- VolitionRx Limited (OTC: VNRX), a life sciences company focused on developing blood-based diagnostic tests, announces that it has filed two new patent applications. The first patent application is an extension to the Nucleosomics technology for the detection of histone modifications in nucleosomes; the second covers the use of Volition's Nucleosomics technology in personalized medicine as a predictor of the efficacy of cancer treatment.
"The use of Nucleosomics in the expanding field of personalized cancer medicine is a new early stage development for us but represents an exciting prospect with the potential for real patient benefit," said Jake Micallef , Chief Scientific Officer of Belgian Volition.
VolitionRx already holds patent applications worldwide for a number of methods of detecting nucleosomes and nucleosome structures; both in-licensed and self-authored.
"These two patents complement our existing Nucleosomics IP, providing us with greater intellectual property protection for our NuQ products," said Cameron Reynolds , CEO of VolitionRx. "While we work towards applying for regulatory approval for our clinical products in both Europe and the US, we continue to carry out research and development in our Belgian laboratory, expanding our intellectual property base and our understanding of the possibilities � both in diagnostics and therapy monitoring � for our Nucleosomics technology.
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Reverse Merger Activity
On October 6, 2011 became a public entity via a reverse merger transaction .
Company Snapshot:
A life sciences company focused on meeting the urgent need for accurate, fast, inexpensive and scalable tests for detecting and diagnosing cancer and other diseases
Industry Snapshot:
Everyone in the world has, or will be, touched by the effects of cancer. It is one of the world’s most deadly diseases, accounting for around 13% of annual global deaths.1 In the United States alone, there are 13.8 million cancer survivors. By 2020, this figure is expected to rise to 18.1 million and the cost of cancer to the U.S. is projected to reach $158 billion.2 These figures are mirrored in all regions of the world and will continue to grow as populations age. This is a large potential market of which diagnostics will be a significant part. The global In-Vitro Diagnostics (IVD) market is forecast to grow at a rate of 6% to reach $50.0 billion in 2012, driven by the increasing health care demands of an ageing population. The market has been growing at a rate of 5-6% in recent years, reaching a value of $36.5 billion in 2007.3 The largest IVD market segment is diabetes diagnostics with a value of $10 billion.4 The cancer IVD market comprising cancer blood and tissue biopsy tests was $4.7 billion in 2008 and growing at 11%>
Post Merger Share Calculation :
2,285,000: Pre reverse merger outstanding shares
6,908,652: Newly issued shares of Common Stock
GeoTeam® best effort calculation of total post reverse merger shares assuming full conversions: 9 , 1 9 3 ,65 2
Financial Snapshot: December Year End
