VolitionRx (NYSE-A:VNRX) Limited said it has made “good progress” in key areas as it announced its results for the year ended December 31, 2021.
The Austin, Texas-based epigenetics company said it had cash and cash equivalents of around $20.6 million at the year-end, compared with $19.4 million 12 months earlier.
In addition, Volition is due to receive a $10 million upfront payment as a result of its subsidiary Volition Veterinary signing a licensing and supply agreement with Heska Corporation.
"I could not be prouder of the team's achievement in securing a global licensing and supply agreement for our Nu.Q Vet Cancer Screening Test with Heska Corporation, one of the industry's leading companies," said Cameron Reynolds, president and group chief executive officer of Volition, in a statement.
READ: VolitionRx strikes exclusive $28M deal with Heska Corp to sell its Nu.Q vet cancer screening test
Volition said its cash burn rate averaged approximately $2 million per month in 2021. The net loss for the year was $27 million versus $20.4 million for 2020, with this increase reflecting non-cash items in addition to new hire staffing costs.
The company signed its first Nu.Q Discover agreement in 2021, with an additional five agreements worth an aggregate of approximately $200,000 on a full-year basis signed since the year-end.
Volition appointed SAGE Healthcare as a non-exclusive licensee and distributor of its Nu.Q Vet Cancer Screening Test for the Asian market last year and said it remains in advanced negotiations with other potential licensing partners.
"Volition Veterinary is an exciting, fast-moving part of our business with clear potential to generate significant revenue for the company, initially under our agreements with Heska and SAGE Healthcare, through both milestone payments and ongoing sales of kits and key components,” Reynolds said.
“We have also made good progress in other key areas including our Nu.Q NETs and Nu.Q Capture programs as we shift gears towards our goal of becoming a commercial company with products," he added.
The company believes the Nu.Q NETs assay will have wide applicability for monitoring diseases with a NETs component (such as COVID-19, influenza, sepsis, autoimmune diseases, and cancer) and potentially to risk-stratify patients for treatment selection.
It expects to register CE marks on its first NETs product, across multiple platforms including ELISA plate, automated beads, and a proof of concept on a very high throughput platform by the summer of 2022.
Volition said the timing of expected completion for each of its US blood cancer studies has been impacted by the COVID-19 pandemic due to sample collection and protocol issues. Given the pandemic, and resultant delays in the larger Non-Hodgkin Lymphoma (NHL) study (of 1500 subjects), the company has taken the opportunity to upgrade the platform to a high-throughput platform which will help facilitate an FDA compliant product.
Consequently, Volition now expects this study to initiate recruitment in the second quarter of 2022 with study completion anticipated in 2023.
A smaller, proof of concept NHL monitoring study is ongoing, but due to missing serial samples as a result of pandemic collection issues, the company is not in a position to publish yet.
“Collection continues and we anticipate analyzing a more complete data set in 2022,” Volition said.
The company said Nu.Q Capture, when used in combination with either sequencing, mass spectrometry and/or Volition's Nu.Q assays, could potentially aid diagnosis, treatment selection, and both treatment and disease monitoring in addition to aiding biomarker discovery. Further to the publication in 2021 of a novel method utilizing Nu.Q Capture and mass spectrometry, Volition is developing a large 1,000-plus patient study in lung, and colorectal cancer with further announcements expected in 2022.
The company said it aims to drive near-term revenue in the following key areas:
- Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet
- Complete Heska Corporation agreement milestones in order to receive further milestone payments
- Sales of key components of Point of Care test with Heska
- Sales of kits from non-exclusive agreements for the use of Nu.Q Vet via central reference labs
- Ongoing and new Nu.Q Discover agreements
- Sales of its disease monitoring tests (e.g. COVID-19, sepsis).
Volition highlighted the following upcoming milestones:
- 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 to treat sepsis
- Continue to advance its previously announced large-scale blood, lung, and colorectal cancer trials in Europe, Asia, and the US
- 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
Volition is a multi-national epigenetics company that has developed simple, easy-to-use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including some cancers and diseases associated with NETosis such as sepsis and COVID-19.
The firm is mainly focused on human diagnostics and monitoring but also has a subsidiary focused on animal diagnostics and monitoring.
Contact the author at jon.hopkins@proactiveinvestors.com