VolitionRX (NYSEAMERICAN:VNRX) outlined what management described as a “transformational” period during its full fiscal year 2025 earnings call, highlighting early steps toward routine clinical use of its Nu.Q platform in both sepsis detection and lung cancer management, alongside continued progress in licensing discussions and cost reductions.
Clinical and commercial highlights: sepsis and lung cancer
Group CEO Cameron Reynolds said the company’s “first clinical use” is now “imminent” in two major disease areas. He pointed to a first order for Nu.Q Cancer assays for clinical certification ahead of routine clinical use in lung cancer, and to the inclusion of the company’s Nu.Q NETs assay in a real-world interventional evaluation program for early detection of sepsis in France.
Andy said this evidence supported Volition’s December announcement that Nu.Q NETs would be used as the “sole biomarker” in DETECSEPS, a real-world evaluation combining H3.1 with the National Early Warning Score to promote earlier sepsis detection and improve emergency room throughput. Reynolds later emphasized that DETECSEPS is an interventional study “used on real people in real life,” with decisions taken based on the test.
For Nu.Q Cancer in lung cancer, Andy said clinical use is “now imminent” and described work from collaborators in Taiwan and Lyon. He highlighted presentations supporting preoperative use, stating that high H3K27me3 nucleosome levels predicted poorer recurrence-free and overall survival outcomes, while lower levels indicated better outcomes. He also said Volition made its first sale of Nu.Q cancer assays to Hospices Civils de Lyon and, after year-end, prepared a reimbursement submission to the French government. Andy called reimbursement “the next step” and said Volition anticipates introduction into routine clinical use in France by the fourth quarter of 2026 “once achieved.”
Capture-Seq: pursuit of “virtually pure” circulating tumor DNA
Chief Scientific Officer Jake Micallef focused on Capture-Seq, which he described as a new approach to address a central challenge in liquid biopsy: most circulating DNA in plasma originates from healthy cells rather than cancer. Micallef said Volition has demonstrated isolation and analysis of “greater than 99% pure” circulating tumor-derived DNA (ctDNA) and submitted an updated manuscript describing a two-step method that includes physical enrichment and bioinformatic removal of remaining non-tumor cfDNA sequences.
Micallef also discussed work involving CTCF bound DNA, saying the company believes there is “almost no” CTCF bound DNA in healthy plasma and “almost all” CTCF bound DNA in cancer patient blood is derived from cancer cells, resulting in “virtually pure” tumor-derived DNA.
He said Volition recently released data from a blinded validation cohort of 81 subjects—59 colorectal and lung cancer patients and 22 healthy controls—and was “extremely encouraged,” particularly in early-stage cancer, where it detected “more than 95%” of stage 1 and stage 2 cancers. Micallef cautioned the potential impact depends on validation in larger cohorts, but said the technology could contribute to multi-cancer early detection and may have applications in cancer management, including minimal residual disease detection and treatment monitoring.
In response to an analyst question, Micallef said the Capture-Seq process involves a magnetic antibody step—similar to an immunoassay—and sequencing, calling it “extremely suitable to be automated.” Reynolds added that the capture component currently may cost around $100 and could decline, while sequencing costs depend on the panel and could range from “a few hundred dollars or $500.”
Nu.Q Discover and veterinary updates
Reynolds said Volition’s 2025 efforts centered on commercialization of the Nu.Q platform and a licensing strategy in human diagnostics. He highlighted two agreements: one related to antiphospholipid syndrome (APS) with Werfen and a co-marketing services agreement with Hologic. Reynolds also said the company is in licensing discussions with around 10 diagnostic and liquid biopsy companies and anticipates additional agreements throughout 2026, with potential for upfront payments, milestones, and recurring revenue.
On Nu.Q Discover, Reynolds said the company is serving close to 100 clients worldwide, including pharmaceutical and diagnostic companies, and referenced a March 2025 agreement with a “leading pharmaceutical company” to use Nu.Q Discover biomarkers in a longitudinal phase I/IIb study. He also said some pharma companies are moving toward late-stage trials using Volition assays as pharmacodynamic biomarkers and estimated the total addressable market for relevant companion diagnostics at “a little under $1 billion.”
In veterinary diagnostics, Reynolds called the Nu.Q Vet Cancer Test the “number one canine cancer screening blood test in the world,” now available in more than 20 countries, and said the company prioritized central lab automation. He noted Fujifilm Vet Systems extended its contract in March 2025 to implement a centralized automated platform using the IDS-i10 made by Revvity, and said that after year-end Volition completed validation and verification of a chemiluminescent immunoassay (CLIA) version in Japan to enable full automation in central labs.
Reynolds also provided an update on feline development, pointing to a clinical study reported after year-end showing the Nu.Q Vet feline assay detected “over 80%” of feline lymphomas at “100% specificity.” He said publication in a peer-reviewed journal is expected to unlock a $5 million milestone payment.
Financial results, cash position, and cost actions
Chief Financial Officer Terig Hughes reported 2025 revenue of $1.7 million, up 40% from 2024, and said fourth-quarter year-over-year growth was 133%. He said the company received its first revenue from the CE Mark Nu.Q NETs product in Europe during 2025 and its first order for Nu.Q Cancer from Lyon for certification in a hospital network. Hughes cautioned that at this stage revenues are “lumpy and difficult to predict,” and the company is not providing 2026 revenue guidance.
Hughes said operating expenses declined by $4.8 million, a 17% reduction versus 2024. Net cash used in operating activities was $19.7 million in 2025, compared with $25.9 million in 2024, and cash and cash equivalents ended the year at approximately $1.1 million.
After year-end, Hughes said Volition received approximately $5.4 million in net proceeds from its at-the-market facility through March 25, plus $1.9 million in net proceeds from a convertible note to Lind Global Asset Management XII LLC. He also cited non-dilutive funding of approximately $2.3 million announced after year-end and said total non-dilutive funding support since inception has exceeded $25 million.
Looking ahead on costs, Hughes said the company is targeting a further 25% to 30% reduction in cash operating expenses in 2026, though he described the timing as gradual and potentially “lumpy,” with the first quarter typically heavier and including severance costs. Reynolds framed the expense reductions as part of a strategic shift from funding internal R&D and studies toward commercialization, with partners and external groups conducting more clinical work.
- 2025 revenue: $1.7 million (up 40% year over year)
- 2025 operating expense reduction: $4.8 million (down 17% vs. 2024)
- 2025 net cash used in operations: $19.7 million (down from $25.9 million in 2024)
- Year-end cash: approximately $1.1 million
In Q&A, Reynolds said the company expects multiple deals in 2026 but did not provide a specific number, emphasizing ongoing negotiations across cancer, NETs, and other pillars. On Nu.Q Cancer volumes in 2026, Hughes said the ramp depends on reimbursement timing, which management characterized as a second-half event, with expectations for routine use by the fourth quarter if reimbursement is achieved.
About VolitionRX (NYSEAMERICAN:VNRX)
VolitionRX, traded as VNRX on the NYSE American exchange, is a pioneering life sciences company focused on the development and commercialization of minimally invasive diagnostic tests for the early detection of cancer and other diseases. Utilizing proprietary technology to analyze circulating nucleosomes in blood samples, the company’s platform identifies disease-specific epigenetic and biochemical signatures. By offering blood-based screening solutions, VolitionRX aims to deliver alternatives to invasive, costly and time-consuming procedures, potentially improving patient outcomes through earlier diagnosis.
The company’s flagship product suite, branded as Nu.Q, comprises assays designed to detect biomarkers associated with a range of malignancies, including colorectal, lung and pancreatic cancers, as well as other systemic conditions.
