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VNRX: Additional clinical papers & company webinars provide insights to Volition’s progress. Nu.Q Discover biomarkers selected for clinical trial. Management continues to focus on signing licensing deals for Capture-PCR & Nu.Q NETs
Nu.Q Discover to be Utilized in a Human Clinical Study
On March 4, 2025, VolitionRx (NYSE:VNRX) made a significant milestone announcement that, for the first time, Nu.Q Discover biomarkers will be utilized in a human clinical study. An unnamed leading pharmaceutical company will be using two Nu.Q Discover biomarkers in a longitudinal Phase 1/2b clinical study. Importantly, the use of Nu.Q Discover assays has transitioned from preclinical research to a clinical trial.
The pharmaceutical company’s decision to incorporate Volition's Nu.Q biomarkers comes after a successful pilot study, in which two of Volition's Nu.Q assays obviously appear to provide biological insights that enhance the stratification of patients in order to personalize therapeutic treatments, to measure disease progression and to improve outcomes. The Phase 1/2b clinical study is expected to be conducted over 12-to-18 months.
Management has indicated that this clinical trial should generate significant revenue for Volition. To put that statement in context, the first Nu.Q Discover agreement was signed in the fourth quarter of 2021. Subsequently, Nu.Q Discover generated service revenues of $92,488 during 2022, and $175,476 in 2023. During the first nine months of 2024, Nu.Q Discover generated service revenues of $155,713. It should be noted that due to the project-based nature of Nu.Q Discover contracts, the revenue stream tends to be lumpy quarter-to-quarter.
Large 971-patient Clinical Study Establishes Nu.Q NETs H3.1 as a Predictor of 28-day Mortality in Sepsis
On January 28, 2025, a clinical study, based on a secondary analysis of the 971-patient SISPCT trial (NCT00832039 on Clinicaltrials.gov), was posted on medRXiv for peer review. The study entitled “Prognostic value of admission H3.1 nucleosome levels in sepsis-associated acute kidney injury: a secondary analysis of the SISPCT randomised clinical trial“ demonstrates that H3.1 nucleosome levels (as measured by Volition’s Nu.Q NETs H3.1 blood assay) have prognostic value in patients with sepsis and septic shock, principally for early mortality and organ dysfunction, particularly for the need of renal replacement therapy (RRT).
The paper indicates that the Nu.Q NETs H3.1 biomarker has a potential clinical utility for risk stratification in critically ill, sepsis patients. For example, all patients with H3.1 levels greater than 20,000 died soon after admission to the hospital. Furthermore, patients with H3.1 nucleosome levels in the 10,000-to-20,000 range experienced a 25% risk of mortality. Additionally, patients with H3.1 nucleosome levels greater than 2,500 nanograms per mil indicate an approximate 3.5-4 times risk of renal replacement therapy according to Forest plot analysis.
By being able to stratify a patient’s risk level by elevated levels of H3.1, therapeutic intervention in critically ill sepsis patients could significantly enhance the management of these cases, enhance physician decision-making and improve patient outcomes.
Virtual Investor Event: Casting a New Light on Sepsis Management
On February 14, 2025, Volition hosted a virtual investor event featuring Dr. Andrew Retter (Chief Medical Officer) and Gael Forterre (Chief Commercial Officer).
Dr. Retter focused on the clinical study based on a secondary analysis of the 971-patient SISPCT trial (described above) as well as the 1,713-patient UMC Amsterdam study that retrospectively analyzed 4,283 samples, which initially showed that higher levels of H3.1 indicated a greater risk of multiple organ failure. The manuscript of the latter UMC Amsterdam study has been submitted, but is not yet available publicly. However, Dr. Retter hinted that the study shows promise in being able to differentiate between hyper- and hypo-inflammatory subtypes of sepsis, which would further help personalize therapeutic treatments for patients.
First Commercial Project Utilizing Rapid High-Throughput Model in the Study of NETosis
On February 6, 2025, VolitionRx announced the company’s first commercial sale its High Throughput Synthetic Sepsis method, which measures activation and inhibition of NETs (neutrophil extracellular traps) in whole blood in real time. This breakthrough allows for monitoring the release of NETs in vivo in real time and being able to monitor crosstalk events in whole blood, along with cellular responses. The ability to measure and monitor the mechanisms at play will lead to a better understanding of uncontrolled NETs formation. The ability to induce and inhibit NETs formation in blood using an automated high throughput system is a result of two years of work.
Volition Showcased Nu.Q® Vet Cancer Test at the 97th WVC Annual Conference
VolitionRx exhibited at the 97th Annual Western Veterinary Conference (WVC) held in Las Vegas between March 2nd and the 5th, 2025. Attendance was approximately 20,000 veterinary professionals. In addition to exhibiting at booth #2943, the company sponsored three (3) events:
"Detect, Treat, Monitor: Navigating the Canine Cancer Journey with Nu.Q® Vet Cancer Test," speaker - Dr. Sue Ettinger, DVM, DACVIM (Oncology) aka Dr. Sue Cancer Vet
"Utilizing the Nu.Q® Vet Cancer Test in Practice," speaker - Dr. Brett Cordes, DVM
"The Nu.Q® Vet Cancer Test - Early Detection with Canine Cancer Screening," speaker: Dr. Tom Butera, DVM (CEO of Volition Veterinary Diagnostics Development LLC)
VolitionRx to Report Full Year 2025 Financial Results
VolitionRx usually reports a business update and provides year-end financial results during the last full week in March.
VALUATION
Utilizing a financial model based on DCF methodology, which forecasts out to 2031, and uses a 10% discount rate (based on CAPM), a 2% terminal growth rate and a terminal P/S multiple of 0.51, the indicated value of VNRX is $3.12 per share.
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