VolitionRx Limited announced financial results and a business update for the quarter ended June 30, 2018. Volition management will host a conference call to discuss these results and provide a further business update tomorrow, August 14, at 8:30 AM U.S. Eastern Time.
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 broad strength of new talent in our team, especially the growth in our research and development team in Belgium who are hard at work on the considerable project of turning our assays into robust products that can be used worldwide. This development work will be a key in our future success and is now very much bearing fruit, including the exciting prostate data we just announced. We are also fortunate to be working with institutions and individuals who have world-renowned reputations.” Mr. Reynolds continued, “the work on the large colorectal cancer product trials is also progressing and we expect to have enough of the product grade assays to be completed to announce more colorectal cancer data later this year, beginning with an updated triage test. We look forward to achieving additional milestones in the upcoming quarters and sharing further exciting news.”
Second Quarter 2018 and Recent Company Highlights
- Signed agreements to conduct two large-scale colorectal cancer research studies across the Asia Pacific region in collaboration with the National Taiwan University.
- The first study will comprise 5,000 asymptomatic colorectal cancer screening subjects and 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.Q™ platform for the detection and diagnosis of colorectal cancer for marketing, rather than for regulatory purposes.
- The studies will cost approximately $2.55 million payable over three years and should assist product development in Asia in 2019.
Signed an exclusive global sales and distribution agreement with Active Motif for a range - of Research Use Only kits, the first of which, the Nu.Q™ Total assay kit is now available for sale. We expect modest initial revenue in the coming quarter, building through next year and beyond.
- Released encouraging preliminary data from a prospective, multi-centered Proof of Concept Study into the utility of Volition’s Nu.Q™ assays to diagnose men with high-grade prostate cancer. At 88% specificity, the Volition assays identified 94% of high-grade prostate cancers that require treatment.
Commenced work on the “Bonn27” study – this 4,500-patient cohort is already collected by the University of Bonn, Germany and includes patients with 27 of the most prevalent cancers. - Started proof of concept work in one of our non-cancer disease areas – endometriosis. This study is in collaboration with the University of Oxford, England which has completed a collection of 350 patient samples over the last three years.
Second Quarter 2018 and Other Financial Results
For the three months ended June 30, 2018, Volition reported a net loss of $4.6 million, or $0.15 per share. This compares to a net loss of $3.5 million, or $0.13 per share in the second quarter of 2017.
Cash and cash equivalents as of June 30, 2018 totaled $11.9 million (excluding the $9 million in gross proceeds from the recent private placement) compared to $10.1 million at December 31, 2017. The net cash outflow in the quarter ended June 30, 2018 was approximately $2.4 million.
As previously announced, in July 2018 we secured approximately $700,000 in non-dilutive funding from the Walloon Regional Government and in August 2018 we completed a private placement (PIPE) with an existing accredited investor of 5 million shares of common stock at a price of $1.80, as well as a warrant to purchase up to an additional 5 million shares of common stock at an exercise price of $3.00 per share payable in cash, for aggregate gross proceeds, before the deduction of offering expenses, of $9 million (excluding the proceeds from any exercise of the warrant). These transactions significantly increase our cash position and strengthen our balance sheet.
Upcoming Milestones
For the remainder of 2018 into early 2019, Volition is targeting several important clinical and commercial milestones, including, among others:
- Data on both the Triage and the frontline colorectal cancer screening products.
- Revenue from the sales of our RUO kits.
- Preliminary “Proof of Concept” data on the validity of our Nu.Q™ technology platform from trials such as the Bonn27 study, another European colorectal cancer trial and the endometriosis study.
- Further clinical data on at least one of the other targeted cancers.
- Securing larger prostate trial(s).
- Obtaining additional key patents in several countries, including the United States.
