On August 11, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the second quarter ended June 30, 2021 (Press release, VolitionRX, AUG 11, 2021, View Source [SID1234586330]). Volition management will host a conference call tomorrow, August 12 at 8:00 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.
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"We have made significant progress on many fronts during the first half of 2021, in particular on all four of the Company’s key pillars: Nu.Q, Nu.Q Vet, Nu.Q NETs and Nu.Q Capture," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "We have also significantly strengthened our balance sheet, our intellectual property portfolio, and our executive team to drive our commercial focus."
An interview with Cameron Reynolds, President and Chief Executive Officer of Volition, Terig Hughes, Chief Financial Officer of Volition, and Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC
Mr. Reynolds continued, "I am delighted that the Nu.Q Vet beta launch has not only been very successful in providing invaluable real-world learnings for our first veterinary product but has also generated a high level of interest in both the licensing and distribution of our veterinary products, and we are actively negotiating potential arrangements on multiple fronts."
Company Highlights
Financial
Cash and cash equivalents as of June 30, 2021, totalled approximately $27.9 million compared with $19.4 million as of December 31, 2020.
Net loss for the second quarter of 2021 was $5.6 million and net cash used in operating activities was $5.4 million for the quarter.
Grant income earned in the second quarter of 2021 was approximately $0.4 million.
Volition received approximately $0.9 million of net proceeds through its at-the-market equity distribution program during the second quarter of 2021.
Continued to manage expenditures carefully with a cash burn rate of approximately $2 million per month.
Personnel
On May 1, Dr. Tom Butera, a seasoned veterinary executive with an extensive commercial track record, and former Non-Executive Director of Volition, joined the team full time as Chief Executive Officer of Volition’s veterinary subsidiary to drive its product launches.
Intellectual Property
27 patent families (plus three in-licensed families) covering both human and animal use of Volition’s Nucleosomics platform.
71 granted patents (ten in the U.S., 14 in Europe and 47 rest of world).
89 patents pending.
Continued focus on filings during the second quarter of 2021 and expect portfolio to grow in the quarters and years ahead.
Publications
Volition’s list of publications and abstracts continues to grow.
Year to date data for Nu.Q has been presented at three international conferences and Volition has collaborated on four clinical papers, three of which have already been published with the other pending publication.
These publications are another very important step forward for the Company.
Nu.Q Vet Cancer Screening Test Beta Launch
Volition has received strong indications of interest in the whole Nu.Q Vet platform, from a range of smaller and very large companies, and it is progressing potential licensing negotiations with several well-known major players in the veterinary space around the world.
The Company aims to have a very meaningful deal signed before the end of 2021.
Clinical – NETosis including COVID-19
Volition believes that the versatility of the Nu.Q platform and the range of applications for which these assays can be leveraged may help increase diagnostic power and monitor disease progression and potentially treatment response across a broad range of diseases that involve the over production of NETs, such as COVID-19, pneumonia, influenza and sepsis.
Volition previously reported preliminary results demonstrating that its Nu.Q NETs assay correlated well with current COVID-19 disease severity.
Recently published posters (at the International Society on Thrombosis and Haemostasis Congress) showed that results on admission using the same Nu.Q NETs assay could predict future COVID-19 disease severity and that serial results correlate with disease progression including 28-day mortality.
From a sepsis product development perspective, to date Volition has completed animal studies in the monitoring of disease progress and treatment efficacy which have demonstrated the effective use of Nu.Q NETs.
The Company has additional large studies in progress related to COVID-19, sepsis and other diseases, some due for completion soon, with the publication of further data expected in the coming months.
Clinical – Cancer
Volition has also been in active and continuing negotiations in Asia this year on its first human cancer launch in China.
The Company has completed preliminary analysis of the lung cancer study conducted with the National Taiwan University and looks forward to reviewing the data with Professor Chen and his team ahead of publication either through clinical paper or conference abstract. Collection has also been completed for the colorectal cancer study also conducted with the National Taiwan University. Volition anticipates the data will be analysed this year, with findings to be presented at a conference in 2022.
After a 15 month pause, EDRN (a large-scale U.S. colorectal cancer study) re-initiated enrolment in June and aims to be enrolling at full capacity in September 2021. The study collection completion date has been extended to the fourth quarter of 2022.
With regards to Volition’s two U.S. blood cancer studies, the timing of expected completion for each has been impacted by the COVID-19 pandemic due to sample collection and protocol issues.
– For the 1,500 subject NHL diagnostic study, all preliminary protocol development and study preparation has been completed. The Company aims to begin collection in late 2021, protocols and pandemic permitting, and to submit the first data to the FDA in late 2022.
– COVID-19 restrictions have also made sequential therapy-matched specimen collections exceptionally difficult in the DLBCL Treatment Monitoring Study. The Company aims to issue interim analysis results later this year.
Volition has installed a Service Lab in Silver One, which will undertake sample processing for external parties such as pharmaceutical companies, biotech companies and academic researchers. This service, branded as Nu.Q Discover, has already generated interest and the Company has provided quotes to multiple pharma and biotech companies. Volition anticipates that it will generate revenue from this activity in 2021 with continued growth in the future.
Upcoming Milestones
Volition expects to achieve the following milestones during 2021 and beyond, pandemic permitting:
Drive revenue in the coming quarters in the following key areas:
– Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet, with the aim of signing the first deal this year,
– Processing samples at Silver One using its Nu.Q Discovery assays, and
– Disease monitoring tests (e.g. COVID-19, Sepsis).
Continue to progress the research program for the use of Nu.Q in NETosis, in monitoring disease progression of COVID-19, sepsis and potentially other diseases and as a possible companion diagnostic for a treatment for sepsis.
Continue to advance its previously announced large-scale blood, lung and colorectal cancer trials in Europe, Asia and the U.S.
Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of its Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend its intellectual property portfolio.
VolitionRx Limited Second Quarter 2021 Financial Results and Business Update
Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations of Volition.
A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source
In addition, a telephone replay of the call will be available until August 26, 2021. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13722250.