VolitionRx anticipates France routine Nu.Q Cancer use by Q4 2026 while targeting 25%-30% 2026 cash OpEx reduction

Earnings Call Insights: VolitionRx (VNRX) Q4 2025

MANAGEMENT VIEW

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CEO Cameron Reynolds said Q4 2025 included “our first order for the new Nu.Q Cancer assays for clinical certification ahead of routine clinical use in lung cancer” and “the inclusion of our Nu.Q NETs assay in real-world interventional evaluation of early detection of sepsis in a government-backed, approximately $7.3 million, program in France.”

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Reynolds said Volition is beginning its “human licensing strategy with the signing of not 1, but 2 agreements,” citing “a co-marketing service agreement with Hologic” and APS with Werfen, and added, “We have further strengthened our intellectual property portfolio and are continuing our licensing discussions with around 10 of the world's leading diagnostic and liquid biopsy companies... and we anticipate announcing additional agreements throughout 2026.”

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Reynolds highlighted traction across pillars, including Nu.Q Discover (“we are now serving close to 100 clients worldwide”) and Nu.Q Vet, where he said central lab automation is “crucial,” and that “the completion of all validation and verification of the chemiluminescent immunoassay, ChLIA, version of the Nu.Q Vet Cancer Test with Fuji Vet Systems in Japan” “will significantly enhance turnaround times and throughput.”

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Reynolds described a feline expansion opportunity, stating that in a lymphoma detection study “At 100% specificity... the assay detected over 80% of feline lymphomas,” and added, “The publication of this study in a peer-reviewed journal is expected subsequently to unlock a $5 million milestone contract payment.”

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CFO Terig Hughes said, “For the full year 2025, we recorded $1.7 million in revenue, a growth of 40% over the full year 2024,” and added, “we significantly reduced operating expenses, which were $4.8 million lower, a reduction of 17% compared to the full year 2024.”

OUTLOOK

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Management said it is not issuing 2026 revenue guidance; CFO Terig Hughes stated, “we will not be providing revenue guidance for 2026 at this point in time.”

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On timing for Nu.Q Cancer volume ramp, CFO Hughes tied uptake to reimbursement timing: “we're in the process of submission preparation for the reimbursement... we'd expect it to be about Q4 by the time we get that reimbursed product into routine clinical use.”

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Management framed 2026 priorities around executing more licensing agreements; CEO Cameron Reynolds said, “Our laser focus is on executing licensing agreements,” and added, “I think I'd strongly suggest we will have multiple deals with different companies, different governments this year.”

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On expense trajectory, CFO Hughes provided an explicit target: “we're targeting take out another 25% to 30% from the cash OpEx this year,” while cautioning that “First quarter is always a little bit heavier and there are obviously some severance costs to take into account.”

FINANCIAL RESULTS

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CFO Hughes reported Q4 year-on-year revenue growth of 133% and full-year revenue of $1.7 million, and noted early human product momentum: “we received our first revenue from the CE-marked Nu.Q NETs product in Europe during 2025” and “our first order for Nu.Q Cancer from Lyon for the certification of our cancer test in their hospital network.”

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CFO Hughes described cost and cash-use reductions, stating operating expenses were down 17% year-over-year for the full year and “Net cash used in operating activities was $19.7 million in 2025... compared with $25.9 million in 2024.”

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On liquidity, CFO Hughes said, “Cash and cash equivalents at the end of the year totaled approximately $1.1 million,” and added that after year-end “we received approximately $5.4 million in net proceeds from our... ATM facility and $1.9 million in net proceeds from issuance of a convertible note to Lind Global Asset Management LLC,” plus “nondilutive funding of approximately $2.3 million.”

Q&A

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Justin Walsh, JonesTrading: asked for “additional color on the current state of the liquid biopsy field” and “takeaways on the failure of the large NHS-Galleri trial”; CEO Cameron Reynolds replied, “we tend not to criticize the other companies,” but said “there is 100% an opportunity for anyone who can develop something which is truly routine, which ours is, low cost and easy to use,” adding Volition is in “a lot of active discussions” and expects “a lot of news on that through the year.”

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Yi Chen, H.C. Wainwright: asked how Nu.Q Cancer volumes ramp through 2026 and how many licensing deals could close; CEO Reynolds said on deals, “it's very hard to know,” but “I'm quite certain we'll have deals,” and CFO Terig Hughes said reimbursement is an “H2 event” with routine clinical use around Q4; Reynolds added, “at the moment, we're not providing guidance, to be conservative.”

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Steven Ralston, Zacks: asked about vet test adoption patterns among partners; CEO Reynolds said centralized labs are the bottleneck, noting “over 80% of testing in dogs is done through a centralized lab,” and that prior reliance on “microtiter plates” made scaling difficult, adding the Fuji automation “will start flowing through,” while revenue remains “lumpy between quarter-on-quarter.”

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Steven Ralston, Zacks: asked whether Europe hospital networks are a model for global emphasis; CEO Reynolds said the strategy is partner-led execution: “we've shifted a lot to our partners doing the work,” and highlighted the French government interventional effort: “an interventional study means it's used on real people in real life, and those decisions are taken based on our test.”

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Bruce Jackson, Benchmark: asked about Capture-Seq lab automation and integration into MRD/liquid biopsy tests; CSO Jacob Micallef said the workflow is “a magnetic antibody... and the second part is sequencing,” adding “it is extremely suitable to be automated.” CEO Reynolds added cost framing: capture “may cost us $100” today and could move to “$60, $70, $80,” while sequencing could be “a few hundred dollars or $500.”

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Bruce Jackson, Benchmark: asked timing of the feline milestone and 2026 OpEx direction; CFO Hughes said, “we do expect to collect it this year,” but it is “difficult to know exactly which quarter,” and reiterated cost actions and the “25% to 30%” cash OpEx reduction target, while warning early-year lumpiness and severance.

SENTIMENT ANALYSIS

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Analysts’ tone was neutral to slightly skeptical, focusing on commercialization timing and competitive context (e.g., Justin Walsh asked about “the failure of the large NHS-Galleri trial,” and Yi Chen pressed on deal count and 2026 assay ramp), while repeatedly seeking clarity on revenue predictability and scale.

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Management tone was slightly positive in prepared remarks and more cautious in Q&A on timing and guidance, emphasizing uncertainty (“revenues remain fairly lumpy,” “we're not providing guidance”) alongside confidence language on strategic direction; CEO Reynolds said, “I'm quite certain we'll have deals,” and framed partner-led scale as central.

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Versus the prior quarter, management continued the same themes (licensing focus and cost control) but sounded more milestone-driven around near-term clinical use; current call language included “first clinical use now imminent” and a more specific reimbursement timing (“by the fourth quarter of 2026”).

QUARTER-OVER-QUARTER COMPARISON

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The current call added concrete clinical-commercial milestones beyond Q3’s partner-and-publication updates, including CFO-reported “first revenue from the CE-marked Nu.Q NETs product in Europe,” and management noting “first order” for Nu.Q Cancer assays for certification and a French reimbursement submission underway.

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Guidance posture remained consistent: both calls said revenue is “lumpy” and management would not provide revenue guidance; however, Q4 included a clearer expense target, with CFO Hughes explicitly targeting “another 25% to 30%” cash OpEx reduction in 2026.

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Q3 centered heavily on signing the Werfen and Hologic agreements and early Capture-Seq manuscript submission; Q4 expanded Capture-Seq discussion with blinded validation cohort data referenced by management and included more detail on automation progress (completion of ChLIA validation/verification with Fuji).

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Analyst focus remained similar quarter to quarter (licensing cadence, revenue visibility, vet ramp mechanics, and cost controls), while Q4 questions broadened to include automation of Capture-Seq and the state of the liquid biopsy field.

RISKS AND CONCERNS

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CFO Hughes highlighted commercialization volatility: “revenues remain fairly lumpy and difficult to predict from 1 quarter to the next,” and said the company therefore “will not be providing revenue guidance for 2026.”

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Liquidity and funding needs remained a focus in disclosed cash figures and financing actions; CFO Hughes reported year-end cash of “approximately $1.1 million” and subsequent funding via the ATM, a convertible note, and additional nondilutive funding.

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Management tied key growth inflection points to external timelines and approvals, including reimbursement; CFO Hughes said routine clinical use in France is expected around Q4 2026, and management repeatedly noted timing uncertainty as a driver for not providing guidance.

FINAL TAKEAWAY

Management framed 2025 as a shift from R&D to commercialization, pointing to first CE-marked Nu.Q NETs revenue in Europe, a first Nu.Q Cancer order for clinical certification in Lyon, and a government-backed ~$7.3 million French sepsis program as near-term validation catalysts. The company reiterated it will not provide 2026 revenue guidance due to lumpiness, while outlining a targeted 25%-30% cash OpEx reduction and continued reliance on licensing and partner-led deployment, with reimbursement positioned as a key step toward routine Nu.Q Cancer use in France by Q4 2026.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/vnrx/earnings/transcripts]

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