VolitionRX Stock price
Is VolitionRX a Top Scorer Stock based on the Dividend, High-Growth-Investing or Leverman Strategy?
As a Free StocksGuide user, you can view scores for all 9,133 stocks worldwide.
StocksGuide Premium
StocksGuide Unlimited
Key metrics
📘 Market Capitalization
📈 What is it?
Market capitalization shows how much a company is currently worth on the stock market.
🧮 How is it calculated?
🏛️ Why is it important?
It helps classify companies by size (Large, Mid, Small Cap) and indicates their market presence and relative stability.
🧮 Calculation
🎯 What does this mean for investors?
- Large-cap companies tend to be more stable, often pay dividends, but may grow more slowly.
- Smaller firms may offer higher growth potential but come with more volatility.
- Market capitalization is a useful indicator of company size — but not a measure of whether a stock is undervalued or overvalued.
📘 Enterprise Value (EV)
📈 What is it?
Enterprise Value represents the total cost to acquire a company — including its debt and excluding its cash reserves.
🧮 How is it calculated?
(= Market Cap + Net Debt)
🏛️ Why is it important?
EV gives a more complete picture of a company's value than market cap alone and is used in key valuation ratios like EV/FCF or EV/Sales.
🧮 Calculation
🎯 What does this mean for investors?
- Enterprise Value shows the true cost of buying a company, including all financial obligations.
- It is more accurate than just looking at market cap, especially when comparing companies with different levels of debt or cash.
- Professional investors prefer EV-based multiples because they better reflect the company’s full financial footprint.
📘 Net Debt
📈 What is it?
Net Debt shows how much debt remains after subtracting a company’s available cash reserves.
🧮 How is it calculated?
🏛️ Why is it important?
It indicates how dependent a company is on borrowed money and how easily it can service its debt in the short term.
🧮 Calculation
🎯 What does this mean for investors?
- Low or negative net debt signals financial strength and flexibility.
- Companies with strong cash positions are better positioned in crises.
- High net debt increases financial risk — especially in environments with rising interest rates or economic downturns.
📘 Cash
📈 What is it?
Cash represents all liquid assets a company can access immediately — including cash, bank deposits, and short-term investments.
🧮 How is it calculated?
🏛️ Why is it important?
It reflects a company’s financial flexibility and resilience — enabling investments, buybacks, or buffer in downturns.
🧮 Calculation
🎯 What does this mean for investors?
- A strong cash position means greater room for maneuver and crisis resistance.
- Cash-rich companies can invest, pay down debt, or repurchase shares.
- But excess idle cash might indicate a lack of growth opportunities.
📘 Shares Outstanding
📈 What is it?
Shares outstanding represent the total number of a company’s shares currently held by investors — excluding treasury stock.
🧮 How is it calculated?
🏛️ Why is it important?
It’s the basis for key metrics like Earnings Per Share (EPS), Market Capitalization, or the Price/Earnings ratio (P/E).
🧮 Calculation
🎯 What does this mean for investors?
- Fewer shares in circulation typically increase earnings per share — making each share more valuable.
- Share buybacks reduce the number of shares and boost per-share metrics.
- Issuing new shares does the opposite — diluting shareholder value and lowering per-share figures.
📘 Price-to-Earnings Ratio (P/E)
📈 What is it?
The P/E ratio shows how many times a company's earnings per share are reflected in its current share price — in other words, how "expensive" the stock appears relative to its profits.
🧮 How is it calculated?
🏛️ Why is it important?
The P/E ratio is one of the most widely used valuation metrics. It helps investors assess whether a stock appears cheap or expensive compared to its earnings power.
🧮 Calculation
📊 P/E (TTM) = Based on earnings from the last 12 months (Trailing Twelve Months):🎯 What does this mean for investors?
- A low P/E may indicate undervaluation — or signal underlying issues.
- A high P/E may reflect strong growth expectations — or an overvalued stock.
📘 Price-to-Sales Ratio (P/S)
📈 What is it?
The P/S ratio shows how much investors are paying for $1 of the company’s revenue – regardless of profitability.
🧮 How is it calculated?
🏛️ Why is it important?
P/S is especially useful for evaluating growth companies or businesses not yet profitable. It reflects how the market values the company’s sales.
🧮 Calculation
Market Cap = $4.77m | Revenue (TTM) = $2.46m
Market Cap = $4.77m | Estimated Revenue = $2.57m
🎯 What does this mean for investors?
- A low P/S may indicate undervaluation — or low profitability.
- A high P/S can reflect strong growth expectations — or excessive optimism.
- Especially helpful when evaluating companies where profits are low, volatile, or negative.
📘 Enterprise Value to Sales (EV/Sales)
📈 What is it?
EV/Sales shows how much investors are paying for $1 of revenue — considering not just equity, but also debt and cash. It’s the capital structure–adjusted version of the P/S ratio.
🧮 How is it calculated?
🏛️ Why is it important?
It’s ideal for comparing companies with different levels of debt. It reflects a company's true cost relative to its revenue.
🧮 Calculation
Enterprise Value = $13.59m | Revenue (TTM) = $2.46m
Enterprise Value = $13.59m | Forward Revenue = $2.57m
🎯 What does this mean for investors?
- EV/Sales allows for capital structure–neutral company comparisons.
- A lower ratio may indicate undervaluation; a higher one may signal strong growth expectations or overvaluation.
- Especially helpful when evaluating high-growth companies with low or negative earnings.
📘 Enterprise Value to Free Cash Flow (EV/FCF)
📈 What is it?
EV/FCF shows how many years it would take for a company to "pay back" its enterprise value using its free cash flow.
🧮 How is it calculated?
🏛️ Why is it important?
It focuses on real cash generation, ignoring accounting noise — ideal for assessing profitability and value based on liquidity, not earnings.
🧮 Calculation
🎯 What does this mean for investors?
- A low EV/FCF may signal undervaluation and strong cash generation.
- A high EV/FCF might reflect weak recent cash flow or aggressive growth expectations.
- Best suited for stable, mature businesses with predictable free cash flows.
📘 Price-to-Book Ratio (P/B)
📈 What is it?
The P/B ratio compares a company’s market value to its book value — showing how much investors are paying for each dollar of net assets.
🧮 How is it calculated?
🏛️ Why is it important?
P/B is commonly used for asset-heavy industries like banks or industrials. It helps assess whether a stock is trading above or below its net asset value.
🧮 Calculation
🎯 What does this mean for investors?
- A P/B below 1 may signal undervaluation — or weak profitability.
- A P/B above 1 implies the market expects future value creation (e.g., brand, IP, growth).
- Best used for companies with tangible assets and strong balance sheets.
📘 Equity Ratio
📈 What is it?
The equity ratio indicates what portion of a company’s total assets is financed by shareholders’ equity – in other words, how much it relies on its own capital.
🧮 How is it calculated?
🏛️ Why is it important?
A high equity ratio reflects financial strength and stability, especially during downturns. It’s a key indicator of a company’s solvency and long-term risk profile.
🧮 Calculation
🎯 What does this mean for investors?
- Companies with high equity ratios are generally more resilient and less dependent on external debt.
- Low equity ratios can signal higher risk or aggressive financial strategies.
- Important: Always assess the equity ratio in combination with the return on equity (ROE). This shows not just how stable the company is – but also how efficiently it uses shareholder capital.
📘 Return on Equity (ROE)
📈 What is it?
Return on equity (ROE) shows how efficiently a company uses its shareholders’ equity to generate profit. In other words: how much net income is earned per dollar of equity.
🧮 How is it calculated?
🏛️ Why is it important?
ROE is a core profitability metric. It helps investors understand whether a company delivers attractive returns on the capital provided by its shareholders.
🧮 Calculation
🎯 What does this mean for investors?
- A high ROE indicates that the company is using its capital efficiently and profitably.
- It’s especially meaningful for capital-intensive businesses or firms with high equity bases.
- Important: A very high ROE can also result from high debt levels – always interpret it alongside the equity ratio to assess financial health.
📘 Return on Capital Employed (ROCE)
📈 What is it?
ROCE measures how efficiently a company generates profits from its total capital – including both equity and interest-bearing debt.
🧮 How is it calculated?
It evaluates the return on all capital employed, regardless of how it’s financed.
🏛️ Why is it important?
ROCE is ideal for comparing companies with different financing structures. It shows how well management uses capital to create value for both shareholders and creditors.
🧮 Calculation
🎯 What does this mean for investors?
- A high ROCE means the company uses its capital efficiently – regardless of whether it's funded by debt or equity.
- The higher the ROCE compared to peers, the more value the company creates with its invested capital.
- Especially relevant for capital-intensive sectors like industrials, energy, or infrastructure.
📘 Return on Invested Capital (ROIC)
📈 What is it?
ROIC measures how efficiently a company generates returns from the capital invested in its core operations – regardless of whether the capital comes from equity or debt.
🧮 How is it calculated?
- NOPAT = Net Operating Profit After Taxes
- Invested Capital = Operating assets minus non-interest-bearing liabilities
🏛️ Why is it important?
ROIC is one of the most accurate indicators of capital efficiency. Unlike return on equity, it is not distorted by leverage and shows how much value is created for all capital providers.
🎯 What does this mean for investors?
- A high ROIC shows how effectively a company uses the capital that is truly invested in its core operations.
- Unlike ROCE, ROIC focuses only on the capital that is actively used to run the business – and that requires a return (i.e. interest-bearing).
- Especially useful when comparing companies with large amounts of excess cash or non-interest-bearing liabilities – giving a more realistic picture of capital efficiency.
📘 Leverage Ratio (Debt-to-Equity)
📈 What is it?
The leverage ratio indicates how much a company relies on interest-bearing debt (such as loans and bonds) relative to its shareholders’ equity.
🧮 How is it calculated?
🏛️ Why is it important?
This ratio helps assess a company’s financial structure and risk profile. High leverage can enhance returns – but also increases exposure to interest rate changes and financial stress.
🧮 Calculation
🎯 What does this mean for investors?
- A low leverage ratio signals financial strength and independence.
- A higher ratio can improve returns in good times but increases risk during downturns or rising interest rate periods.
- 👉 Always interpret in the context of industry, capital intensity, and interest rate environment.
📘 Revenue
📈 What is it?
Revenue shows how much a company earns in total from selling its products and services – the gross income before any costs are deducted.
🧮 How is it calculated?
🏛️ Why is it important?
Revenue is one of the key figures to assess a company’s size, market position, and growth potential.
🧮 Calculation
🎯 What does this mean for investors?
- Growing revenue indicates rising demand and can be an early signal of future earnings growth.
- Comparing actual and expected revenue reveals trends in the market environment and analyst sentiment.
- Note: Strong revenue alone isn’t enough – margins and profitability matter just as much.
📘 EBITDA
📈 What is it?
EBITDA stands for “Earnings Before Interest, Taxes, Depreciation, and Amortization.” It reflects a company’s operating profit before the effects of financing, taxes, and accounting depreciation.
🧮 How is it calculated?
🏛️ Why is it important?
EBITDA is widely used to evaluate a company’s operating performance – especially across capital-intensive sectors or international comparisons.
🧮 Calculation
🎯 What does this mean for investors?
- A high or growing EBITDA indicates strong operational profitability – independent of taxes, interest, or accounting methods.
- It’s especially useful for comparing companies across sectors or geographies.
- Important: EBITDA is not a net income figure – it excludes key costs like depreciation and interest.
📘 EBIT
📈 What is it?
EBIT stands for “Earnings Before Interest and Taxes.” It reflects a company’s operating profit after depreciation, but before interest and tax expenses.
🧮 How is it calculated?
🏛️ Why is it important?
EBIT is a core profitability metric that shows how well the company performs in its main business operations – independent of capital structure and tax environment.
🧮 Calculation
🎯 What does this mean for investors?
- A high EBIT indicates strong profitability from the company’s core business – before financial and tax effects.
- It allows better comparison between companies with different debt levels or tax structures.
- Compared to EBITDA, EBIT already accounts for depreciation and reflects capital intensity more clearly.
📘 Net Income
📈 What is it?
Net income is the company’s total profit – the amount left after all expenses, taxes, interest, and depreciation have been deducted.
🧮 How is it calculated?
🏛️ Why is it important?
Net income is the most comprehensive measure of a company’s profitability – showing how much actual profit remains after all business and financing costs.
🧮 Calculation
🎯 What does this mean for investors?
- Growing net income indicates that the company is managing all of its costs efficiently.
- It directly influences valuation metrics like P/E ratio and the company’s dividend capacity.
- Over time, net income trends reveal how resilient and profitable the business model really is.
📘 Free Cash Flow (FCF)
📈 What is it?
Free Cash Flow shows how much actual cash remains after a company covers its operating expenses and capital expenditures.
🧮 How is it calculated?
🏛️ Why is it important?
FCF reflects a company’s real financial strength – regardless of accounting profits. It shows how much flexibility a company has for dividends, share buybacks, or debt reduction.
🧮 Calculation
🎯 What does this mean for investors?
- High free cash flow means the company generates real, usable cash – independent of reported net income.
- It’s often the most reliable base for sustainable dividends and buybacks.
- Declining FCF can be an early warning sign – even when profits appear stable.
📘 Revenue Growth
📈 What is it?
Revenue growth shows how much a company’s sales have changed compared to the previous year – both on a trailing basis (TTM) and based on forward projections.
🧮 How is it calculated?
Forward = (Expected revenue ÷ Revenue in prior year − 1) × 100
Forward growth is based on analyst estimates for the current fiscal year.
🏛️ Why is it important?
Rising revenue signals growing demand, business expansion, and market share gains – especially important for growth-oriented companies.
🧮 Calculation
🎯 What does this mean for investors?
- Growth is the engine of long-term value creation – especially in tech and growth sectors.
- What matters is not just current growth, but its sustainability.
- Forward projections reflect whether analysts expect continued momentum – or a slowdown.
📘 EBITDA Growth
📈 What is it?
EBITDA growth shows how much a company’s operating profit (before interest, taxes, depreciation, and amortization) has increased or decreased compared to the previous year.
🧮 How is it calculated?
Forward = (Expected EBITDA ÷ EBITDA from prior year − 1) × 100
The forward estimate is based on analyst projections for the current fiscal year.
🏛️ Why is it important?
Growing EBITDA indicates improving operational profitability – regardless of financing or accounting effects.
🧮 Calculation
🎯 What does this mean for investors?
- Strong EBITDA growth signals operational efficiency and scalability – especially during growth phases.
- EBITDA growth can be an early indicator of margin and earnings expansion – but should be assessed alongside revenue and EBIT.
📘 EBIT Growth
📈 What is it?
EBIT growth shows how much a company’s operating profit (after depreciation, but before interest and taxes) has increased compared to the previous year.
🧮 How is it calculated?
Forward = (Expected EBIT ÷ EBIT from prior year − 1) × 100
The forward estimate is based on analyst projections for the current fiscal year.
🏛️ Why is it important?
EBIT growth is a direct indicator of a company’s business performance – taking into account capital intensity through depreciation.
🧮 Calculation
🎯 What does this mean for investors?
- Rising EBIT signals improving operating profitability – even after accounting for depreciation.
- It’s especially important for evaluating companies with significant capital expenditures.
- Combined with revenue and EBITDA growth, EBIT growth provides a well-rounded view of operational progress.
📘 Net Income Growth
📈 What is it?
Net income growth shows how much a company’s bottom-line profit has increased or decreased compared to the previous year – both on a trailing basis (TTM) and based on analyst projections.
🧮 How is it calculated?
Forward = (Expected net income ÷ Net income from prior year − 1) × 100
The forward estimate reflects analysts’ expectations for the current fiscal year.
🏛️ Why is it important?
Net income is the ultimate measure of profitability. Growing net income signals stronger efficiency, cost control, and sustainable earnings power.
🧮 Calculation
🎯 What does this mean for investors?
- Stronger net income boosts valuation, dividend potential, and investor confidence.
- If profits stall while revenue grows, it may signal margin pressure.
📘 Free Cash Flow Growth
📈 What is it?
Free cash flow (FCF) growth shows how a company’s available cash – after covering operating expenses and capital expenditures – has changed compared to the previous year.
🧮 How is it calculated?
🏛️ Why is it important?
Free cash flow reflects real financial strength. Growing FCF indicates more flexibility for dividends, share buybacks, and reinvestment.
🧮 Calculation
🎯 What does this mean for investors?
- Declining FCF may point to rising investments, increasing costs, or weaker operating performance.
- Especially for dividend investors, FCF growth is critical – since dividends are paid from actual available cash.
- A negative trend isn't always bad, but it deserves closer attention.
📘 Gross Margin
📈 What is it?
Gross margin shows how much of a company’s revenue remains after deducting the direct costs of goods sold (like materials and production). It represents the company’s “raw profit” before fixed costs, taxes, and interest.
🧮 How is it calculated?
Or simply: Gross Margin = Gross Profit ÷ Revenue × 100
🏛️ Why is it important?
Gross margin indicates how efficiently a company can produce or procure what it sells. It is a key measure of product-level profitability and pricing power.
🎯 What does this mean for investors?
- A high gross margin suggests strong pricing power and efficient production.
- Falling margins may signal rising input costs or competitive pressure.
- Compared to peers, gross margin offers insights into the quality of a business model.
📘 EBITDA Margin
📈 What is it?
The EBITDA margin shows how much of a company’s revenue remains as operating profit before interest, taxes, depreciation, and amortization.It reflects operating efficiency without being distorted by financing or accounting factors.
🧮 How is it calculated?
🏛️ Why is it important?
The EBITDA margin reveals how much operating income a company generates per dollar of revenue – independent of capital structure and tax effects.
🧮 Calculation
🎯 What does this mean for investors?
- A high EBITDA margin reflects strong core profitability – before accounting distortions.
- It allows for effective comparisons across companies and sectors.
- A stable or growing margin signals efficient cost control and business scalability.
📘 EBIT Margin
📈 What is it?
The EBIT margin shows what percentage of revenue remains as operating profit after depreciation but before interest and taxes.
🧮 How is it calculated?
🏛️ Why is it important?
The EBIT margin reflects a company’s core profitability while accounting for capital intensity (e.g. machinery, infrastructure). It’s especially useful for comparing businesses with different levels of depreciation.
🧮 Calculation
🎯 What does this mean for investors?
- A high EBIT margin shows that the company remains efficient even after factoring in depreciation.
- It’s especially relevant for capital-intensive industries.
- Stable or rising EBIT margins over time are a strong indicator of pricing power and business quality.
📘 Net margin
📈 What is it?
Net margin shows how much of a company’s revenue remains as bottom-line profit after deducting all costs, interest, taxes, and depreciation.
🧮 How is it calculated?
🏛️ Why is it important?
Net margin reflects a company’s overall efficiency – across operations, financing, and taxation. It shows how much actual profit is generated from each dollar of revenue.
🧮 Calculation
🎯 What does this mean for investors?
- A high net margin means the company is not only strong operationally but also manages financing and taxes efficiently.
- Peer comparisons reveal business quality and competitiveness.
- Declining margins despite revenue growth can be a red flag for rising costs or inefficiencies.
📘 Free cash flow margin
📈 What is it?
The free cash flow (FCF) margin shows how much of a company’s revenue remains as actual free cash after covering all operating expenses and capital expenditures.
🧮 How is it calculated?
🏛️ Why is it important?
This margin reflects the true liquidity generated by the business – independent of accounting rules or depreciation. It’s especially relevant for dividends, buybacks, and reinvestment decisions.
🧮 Calculation
🎯 What does this mean for investors?
- A high FCF margin means a company consistently generates strong cash flow.
- It’s a positive signal for financial stability and shareholder returns.
- The long-term trend is key – a declining margin may indicate rising investments or weakening operating efficiency.
📘 Earnings per share (EPS)
📈 What is it?
Earnings per Share (EPS) shows how much profit is attributable to a single share – and is one of the most important metrics for evaluating a company's performance.
🧮 How is it calculated?
The diluted share count reflects potential new shares that could be issued through options, convertible bonds, or other rights.
🏛️ Why is it important?
EPS is the basis for many key valuation metrics like P/E ratio, PEG ratio, or payout ratio. It enables comparisons of profitability across companies, regardless of their size.
🧮 Calculation
🎯 What does this mean for investors?
- EPS captures per-share profitability and is especially useful for comparisons over time or with analyst estimates.
- Rising EPS may signal consistent growth or share buybacks.
- Important: Always use diluted EPS for more realistic valuations – especially in companies with stock-based compensation.
📘 Free cash flow per share (FCF per share)
📈 What is it?
Free Cash Flow per Share shows how much free cash flow a company generates per outstanding share – after investments, but before dividends or debt repayments.
🧮 How is it calculated?
Free cash flow is calculated as operating cash flow minus capital expenditures (CapEx).
🏛️ Why is it important?
FCF per Share reveals how much real cash is available per share – useful for dividends, buybacks, or reducing debt. Unlike net income, free cash flow is harder to manipulate and often seen as a more reliable metric.
🧮 Calculation
🎯 What does this mean for investors?
- High FCF per share signals strong financial flexibility.
- It shows how much capital the company can effectively reinvest or return to shareholders.
- Particularly relevant for dividend payers and capital-efficient businesses.
📘 Short interest
📈 What is it?
Short interest indicates how many shares of a company are currently sold short – that is, borrowed and sold by investors who expect the price to decline.
🧮 How is it calculated?
It reflects the percentage of a company’s shares that are being shorted relative to the total shares available.
🏛️ Why is it important?
Short interest serves as a sentiment indicator: A high value may signal skepticism or bearish expectations – but also increases the potential for a short squeeze if prices rise unexpectedly.
🧮 Calculation
🎯 What does this mean for investors?
- Low short interest usually indicates market confidence in the company.
- High short interest can be a warning sign – or an opportunity if sentiment shifts.
- Especially relevant in volatile markets or ahead of key earnings releases.
📘 Employees
📈 What is it?
The employee count shows how many people a company employs worldwide – offering insights into its size, structure, and business model.
🧮 How is it calculated?
🏛️ Why is it important?
It helps assess operational scale, labor intensity, and cost structure. Combined with revenue and profit, it enables key metrics like revenue per employee or productivity.
🧮 Calculation
🎯 What does this mean for investors?
- A high headcount can signal operational complexity – but also significant growth capacity.
- Revenue per employee is a key indicator of efficiency.
- Especially useful for comparing tech, industrial, or service-heavy companies.
📘 Turnover per employee
📈 What is it?
Revenue per employee indicates how much revenue a company generates on average per employee – a key measure of efficiency and productivity.
🧮 How is it calculated?
The employee count is typically taken from the most recent annual report.
🏛️ Why is it important?
This metric helps compare business models – especially between labor-intensive and technology-driven companies. A high value suggests automation, operational efficiency, or strong value creation per head.
🧮 Calculation
🎯 What does this mean for investors?
- A high revenue per employee indicates a scalable and margin-strong business model.
- A low figure may reflect labor-intensive operations or lower value-add.
- Especially helpful when comparing tech companies to industrial or service sectors.
VolitionRX Stock Analysis
Analyst Opinions
11 Analysts have issued a VolitionRX forecast:
Analyst Opinions
11 Analysts have issued a VolitionRX forecast:
VolitionRX Events
Past Events
|
AUG
14
Q2 2026 Earnings Call
about one month ago
|
|
MAY
15
Q1 2026 Earnings Call
4 months ago
|
|
APR
1
Q4 2025 Earnings Call
6 months ago
|
|
NOV
14
Q3 2025 Earnings Call
10 months ago
|
|
OCT
8
Special Call - VolitionRx Limited
12 months ago
|
StocksGuide Free
VolitionRX — Q2 2026 Earnings Call
1. Management Discussion
Hello, everyone, and thank you for standing by. Welcome to VolitionRx Limited's Second Quarter 2026 Earnings Conference Call. [Operator Instructions] This conference call is being recorded today, August 14, 2026.
I'd now like to turn the conference call over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.
Welcome, everyone, to today's earnings conference call for VolitionRx Limited.
Before we begin, I'd like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance or achievements expressed or implied by these statements. We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. We do not undertake an obligation to update any forward-looking statements made during the course of this call.
Cameron Reynolds, Group Chief Executive Officer, will open the call, providing a summary of key recent achievements and will then hand over to Terig Hughes, Group Chief Financial Officer, to give a financial report. Before returning to Cameron, who will discuss upcoming milestones. We will then open the conference call to a question-and-answer session.
And with that, I'll turn the call over to Cameron.
Thanks, Lou, and thank you, everyone, for joining Volition's earnings call today. As always, we very much appreciate your time given the busy earnings season.
We have made strong progress across all our product pillars so far in 2026. So taking each in turn. First, starting with Nu.Q NETs. Subsequent to quarter end, we issued a comprehensive video update and PDF showcasing the significant scientific and clinical evidence we have amassed relating to our Nu.Q NETs products and listing the extensive base of data now published. Results have consistently demonstrated that our Nu.Q NETs H3.1 assay accurately distinguishes sepsis from noninfectious systemic inflammation is highly correlated with disease severity and provides excellent prognostic utility for outcomes such as organ failure and mortality.
Moreover, Nu.Q NETs provides new and additional information above standard organ failure scores such as APACHE II and SOFA scores. Professor Djillali Annane, one of the world's leading experts in sepsis has stated that he believes Nu.Q NETs could become a game changer in modifying a patient's trajectory and that introducing Nu.Q NETs into hospitals would lead to new ways of treating sepsis, improving patient survival and the quality of life of survivors, a very powerful testament indeed. Excitingly, for Nu.Q NETs, we have also made incredible progress in the development and evaluation of our lateral flow prototype assay. A little over a year ago in July of 2025, we announced the quantification of nucleosomes in whole venous blood using our lateral flow prototype assay. Then in April of this year, we reported a technical breakthrough of being able to detect nucleosomes in capillary blood or blood from a fingerprint.
Now fast forward to earlier this week and our announcement that we have demonstrated the correlation of the lateral flow prototype assay and our established CE Mark automated Nu.Q NETs assay in samples of critically ill confirmed sepsis patients in the intensive care unit. The ability to rapidly identify high-risk patients at the point of care by quantifying their nucleosome levels using a fingerprint sample and simple lateral flow device aims to enable quicker clinical decision-making and consequently better patient outcomes. This prototype technology has the exciting potential to strengthen our product portfolio.
With recent estimates indicating approximately 166 million cases of sepsis worldwide, the potential addressable market is absolutely huge. All caused sepsis-related deaths in 2021 represented 31.5% of total global deaths with the highest burden of mortality in lower and middle-income countries. This is a potential game changer, not only in diseases where time is critical, such as sepsis, but also in significantly expanding potential use cases beyond traditional hospital infrastructure. It also creates a compelling pathway into underserved low-income countries where laboratory infrastructure may be weak or nonexistent. By enabling decentralized testing, our total addressable market expands. More on which later when I discuss upcoming milestones, but we have made and continue to make incredibly rapid progress in the development and evaluation of this finger-prick technology.
Outside of sepsis, but still with Nu.Q NETs and diseases associated with NETosis, we were delighted this quarter to announce our collaboration with Sysmex Corporation, a multibillion-dollar market capitalization company listed on the Tokyo Stock Exchange. Sysmex is a global leader in the field of in vitro diagnostics for hemostasis and thrombosis among other diseases, where neutrophil extracellular traps, NETs play such an important role. We have already successfully transferred our Nu.Q NETs assay onto Sysmex's platform, and we're delighted that they have commenced the optimization phase in disease associated with NETosis.
This collaboration is in addition to that announced last year with Werfen's Immunoassay Technology Center, a worldwide leader in specialized diagnostics. That agreement concerns another NETs-related disease, antiphospholipid syndrome, APS, and they too are making good progress. We believe that Volition's Nu.Q NETs test could provide not only improved diagnostic information to a clinical decision-making and personalized care, but could also be a low-cost test to continue to monitor a patient's condition in many NETs-related diseases.
Next up, Nu.Q Cancer, specifically Nu.Q Lung Cancer. Lung cancer is the major cause of cancer-related mortality worldwide. We believe that Nu.Q Cancer represents a significant advancement in lung cancer patient management, offering clinicians an additional tool to enhance precision in treatment selection and monitoring. Research conducted by our long-term collaborators in Taiwan and Lyon in France demonstrated that our Nu.Q Cancer technology empower clinicians to make more informed treatment decisions and provides valuable new monitoring capabilities throughout the patient journey.
Several manuscripts, conference posters and presentations have already been published and subsequent to quarter end, 2 further papers have been made available on preprint services with a further manuscript due for submission by the NTU team in the coming weeks. This evidence provides the basis of our reimbursement submission supported by our long-term collaborators at Hospices Civils de Lyon, one of Europe's leading cancer centers. This reimbursement is the next step on the path to the first use of Nu.Q in clinical practice, an exciting prospect, which is core to Volition's mission, using our tests to save lives.
This quarter, we participated in our first pre-submission meeting with the authorities and anticipate a follow-up meeting and ultimately a submission by the third quarter of this year. Reimbursement will be a major milestone for Volition in the commercialization and licensing of Nu.Q in the human cancer field. And assuming achievement, we anticipate introduction into routine clinical use in France and then we'll set our sights on rolling it out in other countries. Staying with cancer, but moving on to our Capture-Seq technology. Volition is, I believe, the first company to demonstrate the isolation analysis of greater than 99% fewer circulating tumor associated DNA.
Most current liquid biopsy methods involve deep sequencing of plasma DNA and bioinformatic analysis of the data produced to identify the presence of cancer in a patient. The biggest problem facing all liquid biopsy methods worldwide is that the vast majority of the circulating DNA in blood plasma established from cancer patients comes from healthy cells, not from the cancer. Volition's technology employs an entirely novel approach to liquid biopsy that has overcome this hurdle and produces fewer cancer-associated plasma DNA sequences approach to liquid biopsy. Our clinical paper detailing this technology has been peer-reviewed and published subsequent to quarter end.
The manuscript describes a new liquid biopsy chemistry for isolating CTCF-DNA from plasma. Our work on CTCF-bound DNA has revealed what we believe to be an unprecedented new discovery that there is almost no CTCF-bound DNA in healthy plasma and almost all CTCF-bound DNA in the blood of cancer patients is therefore derived from the cancer. In the published paper, we report a new 2-step method for preparing pure circulating tumor DNA data sets for cancer patients.
Firstly, through physical enrichment of the sample and secondly, through bioinformatic removal of virtually all background nontumor cell-free DNA sequences from the DNA sequence data set. These methodological and surgical breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers Capture-Seq shows potential for both a multi-cancer early detection approach, either alone or in combination with other tests and the detection of minimal residual disease, MRD.
Our goal is to secure a wide range of licensing agreements in the human diagnostic space, mirroring our strategy in the vets market, and we anticipate diverse deal structures with potential for upfront and milestone payments and future recurring revenue. We are in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development of our Capture-Seq technology, and we are in the process of undertaking technical evaluations with potential licensors. We believe the potential use cases for Capture-Seq represent a significant commercial opportunity with a total addressable market on an annualized basis of approximately $23 billion for the human multi-cancer early detection use and should it prove useful over $13 billion for MRD use.
From a Nu.Q Vet perspective, we made solid progress with our research into the use of Nu.Q in cats, most notably with our submission for peer review, our clinical manuscript. This paper reports the high accuracy of our Nu.Q Vet feline prototype assay in detecting lymphoma in cats, the most common cancer in the species. At 97% specificity, the assay detects 86% of feline lymphomas. This breakthrough marks the development of what we expect to be the world's first simple, affordable blood-based liquid biopsy test for feline cancer, a significant unmet need in vet medicine. This opens up the potential for cancer screening and monitoring in cats. There are more than 60 million cats in the U.S. alone, 25% of which are senior cats and thereby suitable for an annual check. We believe this represents a tremendous commercial opportunity for Volition.
The publication of the study in a peer-reviewed journal is expected subsequently to unlock a $5 million contractual milestone payment. And we also expect to generate ongoing revenue in this large and growing market where our technology meets an unmet need. We have made incredibly quick progress from a product development perspective, given it was only in May of last year that we reported detecting nucleosomes in cats, the third species for Nu.Q.
And with that, I'll pass over to Terig for our financial report.
Thanks very much, Cameron, and hello, everyone. I am delighted to provide the financial report for the second quarter ended 30th of June 2026.
After reporting first quarter revenue of approximately $1 million with year-on-year growth of approximately 300%, second quarter revenue performance was more subdued. We recorded approximately $0.4 million in the second quarter, broadly in line with approximately $0.4 million in the same period of 2025. This result reflected higher Nu.Q Vet revenue, offset by lower services revenue from Nu.Q Discover, partly reflecting the timing and lumpy nature of project delivery. Taking the first half in total, total revenue was $1.4 million and year-on-year growth was 112%.
As we have stated previously, at this early stage of commercialization, revenues remain fairly uneven and difficult to predict from one quarter to the next. And so while we remain confident of continuing to see solid growth year-over-year, we will not be providing revenue guidance for 2026 at this point in time. From an expenditure perspective, total operating expenses for the quarter were $4.6 million compared to $6.7 million in the same period last year, a 32% reduction year-on-year. This reflected savings from our cost reduction program, including a 27% reduction in headcount compared to the same point in 2025.
As we reported in the 10-K, looking at the trend over the last 2 years, we now operate at significantly lower levels of expenditure. Furthermore, we have and will continue to take measures to reduce costs further in 2026. Net loss for the quarter was $7.3 million compared to $6.3 million in the same quarter in 2025. This increase was primarily due to noncash accounting charges of approximately $3 million related to the Lind convertible notes, partially offset by the $2.1 million reduction in operating expenses noted above.
Net cash used in operating activities for the quarter was $5.2 million compared with $6.3 million in the comparable 2025 quarter, reflecting the partial impact of cost savings noted above. Cash and cash equivalents at the end of the quarter totaled approximately $2.8 million compared to $1.1 million as at December 31, 2025. Receipts in the second quarter of 2026 included approximately $1.2 million in net proceeds from our at-the-market or ATM facility and approximately $4.1 million in net proceeds from a confidentially marketed public offering of shares and warrants through Maxim Group.
So to summarize the finance report, second quarter revenue was flat year-on-year, however, up 112% year-on-year for the first half of the year. Operating expenses for the second quarter were 32% lower year-on-year. Operating loss was 34% lower year-on-year for the second quarter, and we continue to work on reducing our underlying operating expenses.
I will now pass over to Cameron for a look at what's to come in the second half of the year.
Thank you, Terig. Looking ahead, we have a lot of exciting milestones. Starting with Nu.Q NETs. In addition to the anticipated publication of the feline paper, we also anticipate further development work of the assay as we prepare to commercialize the use of Nu.Q in cats. From a Capture-Seq point of view, we are fast tracking its development, conducting further studies, including competing conditions and larger sample sets and working with oncology key opinion leaders. We also anticipate additional publications and conference presentations in the coming months.
And lastly, but certainly by no means least, we look forward to completing the ongoing and indeed proposed technical evaluations with potential licensing companies. For Nu.Q Lung Cancer, our laser focus is on gaining reimbursement status for the product in France. We also look forward to sharing emerging evidence about the use of Nu.Q Lung Cancer in identifying minimal residual disease, sharing another clinical paper from the NTU team and completing the final validation study with Hospices Civils de Lyon, so lots to look out for.
Regarding Nu.Q NETs, our recent momentum will continue into the second half of the year and beyond. We are now actively targeting NGO partnerships and strategic collaborators with companies operating in low-income countries to accelerate the commercialization and market penetration of our breakthrough lateral flow assay. Working with Professor Djillali Annane and team, we look forward not only to finalizing the 1,000-plus patients IHU study, but also starting the DETECSEPS program planned for September. As a reminder, DETECSEPS is a French government-sponsored real-world evaluation of early detection of sepsis and Volition's Nu.Q NETs is the sole biomarker.
The DETECSEPS program provides an opportunity to receive individualized or personalized care adjusted to the risk of deterioration and progression to sepsis. It is indeed a privilege to be involved in such a program, and we hope that through the early identification of sepsis, lives can be saved. The quality of life of survivors can be improved and importantly, that the burden on the health care systems can be reduced.
As a final note to end on a high, I'm also enormously proud to announce our continued work with the world-renowned Mayo Clinic in yet another potentially significant use of our Nu.Q NETs assay beyond sepsis. You may recall the publication of a study at the Mayo Clinic in the SHOCK Journal earlier this year. The Mayo Clinic study of 674 trauma patients demonstrated that the nucleosome levels as measured by Volition Nu.Q H3.1 and Nu.Q H3R8 Citrulline are elevated in people that have experienced a traumatic event and are even higher in those patients that go on to have complications from the trauma.
The numbers are quite stark indeed and some of the most compelling data that I have seen. H3.1 levels in healthy people were an average of 22.3 nanograms per ml. Those with trauma were 359.7 on average and those that went on to get venous thromboembolism were 828.4, over 37x the level of healthies. The identification of reliable biomarkers in trauma patients is a clinical challenge and remains an unmet need in the emergency and surgical setting. I'm absolutely delighted to confirm that we are now in the process of supplying the Mayo Clinic with an immunodiagnostic systems IDS i10 automated analyzer, our established Nu.Q automated platform.
As Professor Park, principal investigator and senior author of the paper says, "A first step into getting the Nu.Q NETs product into the Mayo Clinic's laboratories." Dr. Park is an intensive care clinician and a translational researcher and is looking to develop a trauma patient model utilizing H3.1 admission. She estimates their clinic sees approximately 2,200 trauma patients per year. She commented. "These biomarkers could aid in early risk identification and may inform targeted preventive strategies in trauma care." For my part, I believe this is a significant study with clear data not only for clinicians, patients and their families, but also for Volition, a peer-reviewed publication with the Mayo Clinic research team can only support our efforts to commercialize our Nu.Q NETs product. The i10 should be placed within the Mayo Clinic this quarter, and we very much look forward to sharing further updates in the coming months.
Finally, in drawing to a close, we have developed a truly remarkable versatile platform and are working with governments, leading hospitals, KOLs and some of the biggest diagnostic and liquid biopsy companies to make our technology available worldwide as quickly as possible. We set out 15 years ago to help save lives and improve outcomes for millions of patients worldwide, and we are making huge progress towards these goals. With the first clinical use now imminent in both early sepsis detection and lung cancer management, we're about to be part of the solution through simple, easy-to-use, low-cost test.
Our vision is for our technology to be incorporated into tests that will be used first by millions and ultimately, hundreds of millions of people and animals a year with our platform license to a range of large diagnostic and liquid biopsy companies and governments worldwide. Combining what we believe to be groundbreaking technology with their installed base of laboratories, analyzed machines and sales forces around the world will achieve the optimal outcome for us. Large companies have the resources to realize the opportunities better than Volition does on its own.
We anticipate that the total addressable market, TAMs for our technologies on an annualized basis are multibillion-dollar opportunities, not only for Volition but for our licensing partners, too. Volition has made strong progress, both clinically and commercially. We are very active with a range of potential partners and are continuing our discussions with more than a dozen of the world's leading diagnostic and liquid biopsy companies to license and commercialize our very broad IP and product portfolio. These discussions are at various stages of the negotiation process across all our different pillars. Our laser focus is on executing licensing agreements, and we'll update you as they progress.
Thank you for joining the call today. We very much appreciate it. We will now take your questions. Operator?
[Operator Instructions] And our first question will come from Michael Okunewitch with Maxim Group.
2. Question Answer
Congrats on all the progress. Just to start off, I wanted to ask about the lateral flow-based NETosis test. It's fairly impressive performance, it seems compared to the venous draw. But if I am interpreting correctly, it does seem like there is a little bit of a loss of diagnostic accuracy as would be expected for the format. So my question is, how might this be applied versus the CE Mark central lab-based test?
Yes, very good question, Mike, and a very good one to go through. So ultimately, in America in a lot of places, the most common test will probably be a lab test. It's easy part of your normal blood draw. It gives you the net numbers, and it goes off as part of the normal blood work. Very helpful things like CRP, which are hundreds of millions of tests per year worldwide in labs, and I think we could certainly be more helpful than that. So a huge market. But if you need a question answered very quickly, even a stat in the busiest hospital will take an hour. You can do a fingerprint test. Also in developing countries, it's extremely helpful where they have less infrastructure. As we talked about, could also be useful things like Ebola.
We talked about cytokine storms in a whole lot of areas. If you have a worried parent or someone who has a child that's sick, you can take it at home as a pinprick. So I think it greatly expands the market. The correlation was 90%. And if you look at the numbers from trauma, for example, that's extremely helpful and actually is incredibly close for 2 completely different formats. For example, I discussed the results for the trauma, the Mayo Clinic, amazing to be working with them. They really think this is a great test, not only where we think in sepsis and other things, but in trauma, which is what, 40 million people a year are admitted for trauma in the U.S. The numbers are quite stark from 22 to 800. So a 90% correlation is obviously going to be very good in all those areas.
So I think that the point of care opens up, it doesn't, by any means, replace a lab. That's the easiest, quickest way for most people to have the test, but I think it opens up a lot of other aspects. And we're in discussions with groups to launch in developing countries, looking with large multinational organizations. And it's something which Volition could also keep a hold of. There's no way we're going to want to launch our own central lab test. That's done by Siemens and Roche and Abbott, that we don't want to compete with them. However, it's something we could contract, manufacture and sell quite easily. So because they correlate so well, means it will be much easier to get them regulatory approval once we have approval on the main platforms as we have with Nu.Q NETs in Europe and the CE Mark on the Revvity machine, it just makes everything easier if the 2 tests agree so well.
I mean they're not exactly the same, but that's 90% correlation although high 80s is extremely good and as good as you could expect. So we're very excited. It opens up all the different markets for Nu.Q NETs. I think it's particularly important for take-home tests and for the developing world. And that was data which is incredibly encouraging, and we're hoping to have a lot more information on rolling that out, hopefully, with large international organizations in the coming months.
All right. I appreciate the additional clarity on that. Just a follow-up. So the point-of-care lateral flow format, right, could this be a proof of concept and have potential for development in other areas like your Nu.Q Cancer test or some of the other nucleosome-based tests that you're doing?
Absolutely. So what we detect is H3.1, which is the basis for obviously the sepsis test. But in theory, everything we develop in either humans or cancer or NETosis sepsis is applicable in animals. It's applicable in all of our range -- of all the nucleosome assays. And we've got other assays for different things. It is certainly in concept, extremely. So for example, the test, which is being launched by Antech in the vet market could absolutely be used in humans or similar ones in humans, those little machines as well as lateral flow as well as the big machines.
For example, the machine that the Japanese now have our vet test automated. That's on the Revvity i10 machine, which is the same as the human machine. And we're working on cats. There's every reason to believe we'll also work on cats. So where H3.1 or other assays, immunoassays work in humans, in NETs in cancer, all of them should work in all the different use cases. And that shows yet again the amazing breadth of what we've developed. So it all fits together very well.
And then just one more from me before I hop back into the queue. I wanted to ask about the feline cancer diagnostic and specifically, how the lower level of specific breed in cats could impact that screening market since it's not like dogs where you can take specific breeds that are at greater risk of certain cancers and much more general population of cats.
Yes, very good question. So we shorthand people often say that the cat market is the same as the dog market in size or even bigger. That's a little optimistic because I don't know if you have a cat, but they tend to be a little more cantankerous and they're not as inclined to go to the vet. So currently, there are a lot less money to be made or visits by cats and dogs to veterinary. But I think that's also what vet companies are trying to improve. Everyone is looking to broaden the market and make more useful tests for more animals. So they're trying very hard to find reasons to bring cats into the vets and give the tests.
And as of today, there's absolutely no current market for any cancer test. There's no cancer test out there in the feline market. So what we're starting with is absolutely the start. And in lymphoma, the data was awesome, 97% specificity, 86% sensitivity. I mean that's even better than it was in dogs. And that was with some very well-renowned vets in different countries collecting the samples. So it's -- I don't think it's fair to say it will double the market for the reasons you mentioned. Also, there are less cat visits, but it's such a large market. There are, I mean, tens of millions of eligible cats around the world. So it would potentially be a very lucrative market. And they do tend to live longer than dogs. So there's a time period.
So it's all something we're working on, but I think any way which you slice and dice it, it's millions or tens of millions of tests per year is the TAM worldwide. And as before, the cost of goods is very low compared to what can be charged for it. So it's a very high-margin product and a big need. So in all our areas, the margins are very good in the process. But the exact size of the cat market, I guess, we'll find out once the product is launched. But I would look at it as a smaller potential market than the dog market, but large nonetheless.
And our next question will come from Justin Walsh with JonesTrading.
It would be great if you could provide some additional color on the reimbursement approval process relevant to Nu.Q Lung Cancer in France. Any potential risk there and how that process compares to comparable processes in other regions?
Yes. It is a different process, and there's always a risk in reimbursement. So nothing by any means is a fait accompli until it's done. But the French government have several programs now where they're trying to encourage more tests to come on the market. And we had our first pre-submission meeting a few weeks ago, and we're still very hopeful of getting this first level approved. It's a bit different from the system in the U.S., and there's quite a few complications. I can probably go through it all offline. But several aspects to your question. We are very, very happy that we're in this process with the French government, and that will allow us to collect a large amount of data once the reimbursements are working in France and start helping people. But it is a different system to the U.S.
So I can go through. It's -- probably take a half an hour go through it. I won't do on this call, but it's a different process. But it's something which we're very happy with how it's going. As I said, we have the pre-submission meeting, and we expect to have the first news on that later this year and be helping people in real life in France next year.
We'll go next to Yi Chen with H.C. Wainwright.
This is Katie on for Yi. Thinking about your revenue quarter-over-quarter, how much of the first half's growth was onetime deferred revenue versus catch-up versus organic growth and ramp? And what do you expect your underlying run rate growth trajectory to be?
Terig, do you want to run through that question.
Yes. Thanks, Katie. This is Terig. Yes, it's a good question. We -- in the quarter, we did have probably a 50-50 split between deferred revenue and actual product revenue. That deferred revenue is coming from the Heska agreement. So as we ship tests in the vet space, we recognize a portion of that revenue, and that's over the life of the agreement. And we'd expect something similar going forward through the balance of the year. So again, we're not providing guidance on individual lines, but we would expect a similar performance over the balance of the year. Does that answer your question?
Yes. Sorry. A quick follow-up. Should we expect quarterly revenue to keep -- be inconsistent? Or are we expecting it to smooth out over time? Are there specific deals coming up that change H2?
At this stage, and that's why we're not giving guidance, it is particularly lumpy. And we're not expecting it to smooth out anytime soon. Part of it is shipping of large orders. Part of it is Discover Services, which is dependent on project revenue being recognized, and that's where you saw we had a fairly flat quarter this quarter, partly because of the timing of the project delivery in Discover Services. We do have a good pipeline of large projects, but we are subject to our partners' timelines to a certain extent in terms of how we recognize that. But again, we expect to see growth over the full year. It's difficult to say one quarter to the next, but I'm confident that over the full year, we will show growth.
And our next question will come from Bruce Jackson with StoneX.
First, could we get an update on the projects that are ongoing in Taiwan?
You want me to take that, Cam?
I think Cam might have dropped off.
He might have dropped off. I can take that Bruce. It's Lou. So in terms of Taiwan, I don't know if you recall that they presented a poster at the NACLC in the U.S. in December and then also again at ELCC this March, and it was around prognostication. And so actually, they've really been focused around this risk stratification for patients ahead of surgery. So they've actually not been -- they've not completed the data analysis for the screening section yet of the study because they've been writing up the paper for the prognostication. And this is really helping, they're looking to introduce it into routine clinical practice now, really looking at the measurement of H3K27 ahead of surgery to help identify those patients that they need to follow up more closely. So that paper should be submitted within the next couple of weeks, and we'll put it up on a preprint service so people can see, but that's why we haven't yet reported the data on the screening study.
Okay. And then in terms of the feline milestone payment, what's your latest thinking on the timing of receiving that?
Yes, shall I take that one? So the paper has been submitted, as you know, and it's still going through a peer review process. We are waiting for reviewers comments to come back. It is taking a little bit longer than we had hoped. But I think it's just a matter of time before that gets published. And then yes, then that would complete our obligations in terms of the milestone.
And we'll go next to Steven Ralston with Zacks.
I appreciated the update on the SUMMIT program. Since the fingerprint sample roughly mirrors the accuracy of the Spearman and Pearson correlations, would clinical trials be required to prove the time to result benefit? In other words, what will be the regulatory pathway for this?
So I think the next steps on that program, so as you know, it's a program that's funded by the Walloon Region. And so we're working together with a team there over in Belgium. The next steps are -- because this has definitely been like the technology and the feasibility stage. The next stage is that it then will make the assay into research use only status so that it goes through some more quality checks, et cetera. And then it will be tested again in 3 independent hospitals for clinical validation. So that will then be the clinical validation stage that we hope to start in early 2027.
I'm back, sorry, [ my phone rang ] out. Yes, so Steven, it's one of those things. So when having things correlate very well, makes the regulatory process much better for de novo in different countries. And obviously, it's much easier if it agrees with what's currently approved in Europe and the process, as you said, with a very strong correlation. But that's not to say that there's never going to be any more regulatory work for it, but it just makes a lot easier if it agrees with the current tests, which are in the lab test. So the gold standard will still be the -- currently the Revvity machine, and we're working with other companies to get that done.
But at the moment, it's just very -- it's encouraging from a whole lot of ways. It means our platforms are both very stable. They're most measuring the same thing. But as I discussed briefly with Mike from Maxim, it's -- the numbers are quite a huge difference. When you're talking 37x healthy level in the most extreme cases for thrombosis, for example, it's -- both have worked extremely well. So the short answer is there will still be regulatory work needed, but we're also looking to use it internationally. So each one of those areas will have a slightly different path. But in a lot of different ways, having it correlate so well with our current Revvity machine, which is the gold standard, it helps us tremendously in getting it out there. Does that make sense?
Yes, yes. Looking at it a different way, management has successfully reduced the quarterly operating expenses from over $8 million per quarter back in 2023 to down to $5.2 million in the most recent quarter. And you relayed some anticipated milestones that could bolster the cash runway in the near term. You've already entered into some agreements to give -- that provide upfront cash payments and milestone payments. Have any of the discussions advanced to the level of co-developmental funding?
Yes. So we -- obviously, we got to be a little careful because there is a lot of different discussions going and they are confidential. I don't want to break any of the agreements we have. But the agreements kind of -- and this is probably a good chance just to review where we are with all the different people we're talking to. They kind of come into several categories. There's the [ autoimmune ] agreements, which are with multi -- currently 2, we're working on 2 multibillion-dollar companies, Werfen and Sysmex.
And as you said, they progressed very well and they're progressing through the stages of co-development. They're working on their machines, and now we're working through the next phases. We did have a deal with Revvity, which is obviously their machine and they're co-marketing our CE Mark kits to dozens of hospitals in Europe. It's a CE Mark kit they're selling. That's progressing well, and we're looking for a bigger agreement with them, and that's progressing well. We have an agreement with Hologic to help co-market our Nu.Q Discover. And as you probably know, Hologic, they're a very large company as well.
We're in discussion with several very large diagnostic companies on our Nu.Q NETs beyond autoimmune and those other ones which we've already signed. And as you can see, the data is looking better and better with the Mayo Clinic, also with the large French DETECSEPS starting collection next month. Also, we're expecting data from a very large study called RECORDS as well, which was over 1,000 also in France. And they're progressing, but they were waiting for some of this bigger data, but that's certainly starting to come through.
So we're hopeful of moving them along. There's a handful, actually more in the cancer space on the Capture-Seq side and those -- some of the evaluation work has already been -- is well and truly worked through. And then there's a range of other things we're licensing, but we'll go through that later. Then also there's all the commercialization, which is working on lung prognostic in Taiwan, in Lyon and also actually, we're going through some other stuff, which is progressing very well in Japan as well.
So lots of different areas, and they're all at kind of different stages and processes. I guess, like everyone, everyone wants to go as quick as they possibly can because that's what's going to get us at the other side of all the things going on and actually licensed. But we currently have 4 agreements signed with multibillion-dollar companies, Werfen, Sysmex, Revvity and Hologic, and we're working on over a dozen others in those 3 main areas and governments and large companies.
So the secret to unlocking all that is more information on the human cancer side, which we're getting valuations as well as for the Capture-Seq as well as H3K27, all the Nu.Q NETs work in trauma and sepsis. And as you heard, we're progressing very well with the Mayo Clinic and then i10 is now being put in their labs, so they can do a lot more work, and we're hopeful of them becoming a customer as well -- I mean, running -- a customer in the sense of running the test for us as well commercially. So yes, it's always -- everyone wants to be quicker, of course, including us, but there's been a lot of progress on all those different fronts. Does that help answer your question as much as I can?
Yes. Thank you for the very meaty explanation of your pipeline here in the near future.
And we'll go next to Ilya Zubkov with Freedom Capital Markets.
I have just a quick one because Discover Service revenue was 0 in Q2, and you said it was because of project delivery timing. So I'm just wondering, were these projects expected in Q2 simply pushed into Q3? Or has there been any change in the underlying size or conversion rate of [ Discovery ] pipeline?
Terig, do you want to answer that?
Yes. This is Terig. It's not that they were necessarily expected in Q2. But as I said, it is always a challenge to predict when some of these projects will start. I mean we're dependent on the timelines of our partners when they start clinical trials or other projects so that we can then deliver those and recognize the revenue. That uncertainty doesn't change over the next couple of quarters. But like I said, we do have a pipeline of projects. And so it would be expected that some of those will drop, but it's very difficult to predict which ones will start in which quarters. Does that answer the question?
And that concludes our question-and-answer session. I would like to turn the floor back over to Cameron Reynolds for closing comments.
Thank you all for joining us today and thank you for the analysts for all those great questions. And I hope it's been helpful in outlining where we're going and the progress we're making on all the areas we're doing and that we're very much focused on getting some of these deals. We've progressed 4 multibillion-dollar companies as we talked about, but we're working on a lot of other and potentially much larger deals, and we hope to update you in short and medium term with how they're all going and some of them being completed. So thank you for your time and take care.
Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines, and have a great day.
VolitionRX — Q1 2026 Earnings Call
1. Management Discussion
Hello, everyone. Thank you for standing by. Welcome to VolitionRx Limited's First Quarter 2026 Earnings Conference Call. [Operator Instructions] This conference is being recorded today, May 15, 2026.
I'd now like to turn the conference call over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.
Thank you, and welcome, everyone, to today's earnings conference call for VolitionRx Limited.
Before we begin, I'd like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties and assumptions. Actual results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance or achievements expressed or implied by these statements. We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. We do not undertake an obligation to update any forward-looking statements made during the course of this call.
Terig Hughes, Group Chief Financial Officer, will open the call providing a financial report before handing over to Cameron Reynolds, Group Chief Executive Officer, who will provide a summary of recent key achievements and upcoming milestones. We will then open the conference call to a question-and-answer session.
And with that, I'll turn the call over to Terig.
Thanks very much, Lou, and hello, everyone. I'm delighted to provide a financial report for the first quarter ending 31st of March 2026.
From a revenue perspective, we recorded approximately $1 million in the first quarter compared to approximately $0.2 million in the same period of 2025. This increase was primarily driven by a $0.7 million increase in deferred revenue recognition related to our Nu.Q Vet agreement with Heska, the result of a periodic review and consistent with our accounting policies. As we have stated previously, at this stage of commercialization, revenues remain fairly lumpy and difficult to predict from one quarter to the next. And so while we remain confident of continuing to see solid growth year-over-year, we will not be providing revenue guidance for 2026 at this point in time.
From an expenditure perspective, the operating expenses for the quarter were $6.3 million compared to $5.8 million in the same period last year. This increase partly reflected severance costs related to cost reduction actions, which will result in future savings as well as higher R&D costs related to work on our Capture-Seq and completion of certain lung cancer studies. As we reported in the recent 10-K, looking at the trend over the last 2 years, we now operate at significantly lower levels of expenditure. Furthermore, we have and will continue to take measures to reduce costs further in 2026.
Net cash used in operating activities was $5.3 million compared with $4.3 million in Q1 2025, partly reflecting the timing of supplier payments. Cash and cash equivalents at the end of the quarter totaled approximately $3.1 million compared to $1.1 million at the end of December 2025. Receipts in the first quarter included approximately $5.4 million in net proceeds from our at-the-market or ATM facility and $1.9 million in net proceeds from issuance of a convertible note to Lind Global Asset Management LLC. We also continue to receive significant support from agencies of the Walloon Region in Belgium with non-dilutive funding of approximately $1 million received and an additional approximate $0.9 million expected to be received in tranches based on certain time and event milestones over the next 12 months. This takes the non-dilutive funding support from all sources from inception to date to well over $25 million.
So to summarize the finance report, revenue was up 300% year-on-year. Operating loss was 3% lower year-on-year. We continue to work on reducing our underlying operating expenses. And as reported, we have made progress to secure a $5 million milestone payment from an existing agreement in the vet space.
Last but not least, licensing discussions are progressing well. And to provide further detail, I will pass over to Cameron.
Thank you, everyone, for joining Volition's earnings call today. As always, we very much appreciate your time given the busy earnings season. The first quarter call always comes hot on the heels of the K, so I will try and be brief today. We have made some strong progress across all of our product pillars this year. So taking each in turn. Nu.Q Vet. The first quarter is always a busy conference season for the vet team, and this year was no different with a booth and sponsored symposium at both VMX and WVC, the 2 largest veterinary conferences in the world.
In March of this year, we announced the completion of all validation and verification of the chemiluminescent immunoassay ChLIA version of the Nu.Q Vet Cancer Test with Fuji Vet Systems (sic) [ Fujifilm Vet Systems ] in Japan, allowing use of full automation rather than manual plates in central labs for dogs. This is a world first for us and will significantly enhance turnaround times and throughput to meet increasing demand. We believe that central lab automation is crucial for scaling our vet business and integrating our test into routine pet wellness panels. Importantly, this automation platform is the same technology utilized for our human diagnostic products, Nu.Q Cancer, Nu.Q NETs and Nu.Q Discover, highlighting the inherent synergy and efficiency of our core Nu.Q platform.
From a product expansion perspective, we have also made great progress with our research into the use of Nu.Q in cats. Subsequent to quarter end, we announced the submission for peer review of a clinical manuscript reporting the high accuracy of our Nu.Q Vet feline prototype assay in detecting lymphoma in cats. The most common cancer in the species. At 97% specificity, the assay detected 86% of feline lymphomas. This breakthrough marks the development of what we expect to be the world's first simple, affordable blood-based liquid biopsy test for feline cancer, a significant unmet need in vet medicine. This opens up the potential for cancer screening and monitoring in cats. There are more than 60 million cats in the U.S. alone, 25% of which are senior cats and therefore, suitable for an annual check. This represents a tremendous commercial opportunity for Volition.
The publication of this study in a peer-reviewed journal is expected to subsequently unlock a $5 million contractual milestone payment. And we also expect it will generate ongoing revenue in this large and growing market where our technology meets an unmet need. Incredibly quick progress from a product development perspective, given it was only May of last year that we reported detecting nucleosomes in cats, the third species for Nu.Q.
Next up, Nu.Q NETs. NETosis really is an area of increasing scientific interest with a significant number of research articles published in recent years. I've spoken before about a number of manuscripts relating to the use of our Nu.Q NETs assay in sepsis. And this quarter, we reported findings in 2 further clinical indications. Firstly, in January, we shared a new clinical study demonstrating the use of Nu.Q NETs in patient management of a chronic disease, HS, a lifelong disease, which affects approximately 1% of the world's population.
HS is a complex immune-mediated disorder with multiple pro-inflammatory cytokines contributing to its pathogenesis. The clinical presentation may also vary from person to person, making it challenging to manage. The findings described in the manuscript demonstrate that for the first time in an easy-to-measure blood test, Nu.Q NETs can be used to classify patients and to surrogate response to treatment. In February, we sponsored a well-attended satellite symposium with key opinion leader, Professor Evangelos and are continuing further work in the field. We look forward to sharing further data as it becomes available. From a chronic disease use case to very much an acute use case.
Secondly, at the end of the quarter, we were delighted to announce the publication of a study at the Mayo Clinic in the SHOCK Journal. The Mayo Clinic study of 674 trauma patients demonstrated that nucleosome levels as measured by Volition's Nu.Q H3.1 and Nu.Q H3R8 Citrulline are elevated in people that have experienced a traumatic event, and are even higher in those patients that go on to have complications from the trauma. The numbers and data are quite stark and some of the most compelling data I have ever seen.
H3.1 levels in healthy people were low at 22.3 nanograms per ml. Those with trauma were elevated to 359.7 and those that went on to get Venous Thromboembolism, VTE, were 828.4 on average, over 37x the level in healthies. The identification of reliable biomarkers in trauma patients is a clinical challenge and remains an unmet need in the emergency and surgical setting. Professor Park, the principal investigator and senior author from the Mayo Clinic said, these biomarkers could aid in the early risk identification and may inform targeted preventative strategies in trauma care.
For my part, I believe this is a significant study with clear data, not only for the clinicians, patients and their families, but also for Volition, a peer-reviewed publication with the Mayo Clinic research team can only support our efforts to commercialize our Nu.Q NETs products. The Mayo Clinic team have continued their work with Nu.Q and are very much looking forward to sharing further updates in the coming months.
Next up for Nu.Q NETs, a quick update on the DETECSEPS program. As a reminder, DETECSEPS is a French government-sponsored real-world evaluation of the early detection of sepsis and Volition's Nu.Q NETs assay is the sole biomarker. The DETECSEPS program provides an opportunity to receive individualized and personalized care adjusted to the risk of deterioration and progression to sepsis.
I'm very pleased to be able to say the program is on track, and we hope the first patient will be recruited in the third quarter of this year, likely September. It is a privilege to be involved in such a program, and we hope that through the early identification of sepsis, lives can be saved. The quality of life and survivors can be improved and importantly, the burden on the health care system can be reduced.
Also, subsequent to quarter end, we were delighted to report the breakthrough finger-prick detection of nucleosomes, thereby expanding global market potential for sepsis testing. This was a major technical milestone, the successful detection of nucleosomes in capillary blood from critically ill sepsis patients using our lateral flow prototype. This finger-prick test sample could be used at the bedside in the emergency room or even at home with a self-test lateral flow kit, similar to COVID-19 or pregnancy testing, thereby greatly expanding the potential market beyond centralized lab testing.
The ability to rapidly identify high-risk patients at the point of care by quantifying the nucleosome levels using a finger-prick sample and simple lateral flow device could enable quicker clinical decision-making and consequently better patient outcomes. We believe this is a potential game changer, not only in diseases where time is critical, such as sepsis, but also in significantly expanding potential use cases beyond traditional hospital infrastructure. It also creates a compelling pathway into underserved low-income countries where lab infrastructure may be weak or nonexistent, an exciting development and one to keep an eye out for the future updates.
Next, I'd like to talk about our Nu.Q Discover pillar, where we are commercializing our service offering for nucleosome-based biomarkers to drug developers and researchers. The first quarter, we were excited to expand our collaborator network and extend the access to Nu.Q Discover through a nonexclusive agreement with Medical & Biological Labs Co. MBL. MBL is a leading provider of clinical research tools in Japan with a particular focus and track record in autoimmune diseases. Through our Nu.Q Discover pillar, we are now serving close to 100 clients worldwide including many top pharma and diagnostic companies, accelerating disease research and drug development across multiple therapeutic areas.
Some of these pharma companies are progressing to late-stage clinical trials using our assays as pharmacodynamic biomarkers. Subsequent to quarter end, we launched our rNuQ webshop, offering a range of reliable, ready-to-use recombinant nucleosomes that we have developed over the past 10 years. Manufactured in our ISO 13485 certified facility, delivering reliable reproducibility and quality control. Volition's nucleosomes are stored and shipped at plus 4 degrees in glycerol-free buffer, simplifying handling while preserving structural integrity and experimental performance, thereby providing rapid access to high-quality nucleosomes for epi-drug researchers worldwide. This is a potential new source of revenue on our path to commercializing our very large IP portfolio.
Moving on to Nu.Q Cancer and specifically Nu.Q Lung Cancer, where the first clinical use of Nu.Q is now imminent. Nu.Q Cancer represents a significant advancement in lung cancer patient management, offering clinicians an additional tool to enhance precision in treatment selection and monitoring. Research conducted by our long-term collaborators in Taiwan and Lyon demonstrates that our Nu.Q Cancer technology empowers clinicians to make more informed treatment decisions and provides valuable new monitoring capabilities throughout the patient journey. Several manuscripts and conference posters and presentations have already been published and several more clinical papers have either recently been submitted for peer review or will be in the coming weeks.
Together, this evidence provides the basis of our reimbursement submission supported by our long-term collaborators at the Hospices Civils de Lyon, one of Europe's leading cancer centers. Reimbursement is the next step on the path to the first use of Nu.Q in clinical practice, an exciting prospect, which is core to Volition's mission, using our tests to save lives. This submission is a significant undertaking, and we hope to participate in pre-submission meetings with the authorities in the coming weeks. Reimbursement will be a major milestone for Volition in the commercialization and licensing of Nu.Q in the human cancer field. And once achieved, we anticipate the introduction into clinical routine use in France late this year.
The final pillar, which has generated a tremendous amount of interest this quarter is Capture-Seq, which we have had several announcements about. Volition is, I believe, the first company to demonstrate the isolation and analysis of greater than 99% pure circulating tumor-derived DNA, ctDNA. To set the scene, the biggest problem facing liquid biopsy worldwide is that the vast majority of circulating DNA in the blood plasma samples comes from healthy cells, not cancer cells. In a world-first new technology, Volition has overcome this hurdle and produced greater than 99% pure cancer-derived plasma DNA sequencing sets for liquid biopsy. We resubmitted our manuscript in March available to view on Research Square.
Our continuing work on CTCF-bound DNA has revealed what we believe to be an unprecedented new discovery that there is almost no CTCF-bound DNA in healthy plasma and almost all CTF bound in the blood of a cancer patient is derived from cancer cells, i.e., it is virtually pure circulating tumor-derived DNA. Removal of background normal cell-free DNA from the blood to reveal this level of tumor-derived DNA has been a long-term goal of liquid biopsy. In the updated manuscript, we report a new 2-step method for preparing virtually pure circulating tumor DNA sets for cancer patients. Firstly, physical enrichment of the samples; and secondly, bioinformatic removal of virtually all remaining non-tumor cell-free DNA sequences from the DNA sequences data set. This new method produces greater than 99% pure tumor DNA sequencing data sets for blood samples from cancer patients.
And whilst we capture a subset of the tumor DNA, not all the tumor DNA in a sample, it is virtually pure cancer DNA. These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers, representing, in our Chief Scientist's opinion, the biggest scientific breakthrough in cancer testing and monitoring in recent years. In addition to the manuscript, we also released data this quarter from a blinded validation cohort of 81 subjects, colorectal and lung cancer patients being 59 and healthy controls being 22. And we are extremely encouraged by the results, particularly in early-stage cancer detection, where we detected over 95% of Stage 1 and 2 cancers.
For patients, the potential significance is huge. If further validated in larger cohorts, CTCF Capture-Seq could contribute to multi-cancer early detection, fulfilling a significant unmet clinical need. We also believe Capture-Seq has the potential to play a role in cancer management, including, but not limited to, minimal residual disease detection, including tumor-naive MRD, and treatment monitoring, either alone or potentially in combination with other technologies. Volition is, I believe, the first liquid biopsy company to focus on circulating cell-free nuclear proteins, and we have filed a number of new patents to protect this technology.
Our goal is to secure a wide range of licensing agreements in the human diagnostic space, mirroring our successful strategy in the vet market. And we anticipate diverse deal structures with potential for upfront and milestone payments and future recurring revenue. We have developed a truly remarkable versatile platform, and we are now working with governments and some of the biggest diagnostic and liquid biopsy companies to make our technology available worldwide as quickly as possible. We have continued to make good progress. Indeed, I would say that we are delighted to have grown the commercial interest in CTCF in the first quarter with an increase in discussions, including for technical evaluations. We set out 15 years ago to help save lives and improve outcomes for millions of patients worldwide, and we are making huge progress towards that goal.
With the first clinical use now imminent, in both early sepsis and lung cancer management, we are about to be part of the solution through simple, easy-to-use, low-cost tests. Our vision is for our technology to be incorporated into tests that will be used by first millions and ultimately hundreds of millions of people and animals a year, with our platform licensed to a range of large diagnostic and liquid biopsy companies and governments worldwide. Combining our groundbreaking technology with their installed base of labs, analyzer machines and sales forces around the world, we aim to achieve the optimal outcome for us. Large companies have the resources to realize the opportunities better than Volition.
The total addressable market, TAMs, for our technologies on an annualized basis are multibillion-dollar opportunities, not only for Volition, but for our licensing partners, too. Volition has made strong progress, both clinically and commercially. We are very active with a range of potential partners, and we are continuing our discussions with more than a dozen of the world's leading diagnostic and liquid biopsy companies to license and commercialize our very broad IP and product portfolio. These discussions are at various stages of the negotiation process across all of our different pillars. Our laser focus is on executing licensing agreements, and we'll update you as they progress.
Thank you for joining the call today. We very much appreciate it. We will now take your questions. Operator?
[Operator Instructions] Our first question comes from the line of Justin Walsh with JonesTrading.
2. Question Answer
I was curious if you could expand on the potential clinical utility of Nu.Q NETs in HS. I'm wondering how physicians might use the additional information to inform treatment decisions.
Yes. Thank you. A lot of that work has been done by Professor Evangelos, who's one of the world's leading experts in HS. And as we said on the call, we've had a satellite symposium. We're actually working with a lot of other groups getting further data. I won't go through the technical side. HS is a tricky complicated condition. But what I do know is some of the world's best people are very keen on how it can be used to help. It is 1% of the world's population, which honestly was news to me. I'm not familiar with the condition myself, but it's supposed to be an extremely painful, extremely debilitating condition for a lot of the world's people.
And Professor Evangelos' paper and now I believe other groups are working on it as well, are very convinced that it could be a very big part of the solution. But yes, I'm not the scientist involved. I'll put you over to Louise, do you want to?
I can add a little bit of color, Justin. So the way that Professor Evangelos has used it thus far is really in helping identify patients that might be having a flare-up. So it's a chronic condition that is kind of often lifelong, and can be under control with treatment, and then people can unfortunately experience flare. And so really, they're using the Nu.Q NETs assay to help monitor patients on an ongoing basis. His hope is actually to then to utilize it within clinical studies of new therapeutics that are coming through. So that's kind of the direction of travel for HS. So I think it's definitely one to keep an eye on. I think we'll have more news out about it throughout the year.
And the current diagnosis is -- I've actually spoken to a Professor Evangelos few times, is a very complicated process. So they're really hoping to simplify it, and he believes that's possible with our test. And just as a background, I guess, obviously, in the NET space, there are so many potential uses, obviously, working with Werfen on APS, another autoimmune disease. Obviously, with the French government that's doing this large interventional study in sepsis. So that's all looking processed. And of course, I mentioned we're incredibly excited with the Mayo Clinic data. Trauma is, I believe, the biggest cause of emergency in intensive -- emergency visits in the U.S. I think, 40 million a year. And obviously, it's something tough to diagnose whether you have trauma or not. So I don't know if you had a chance to look at the data, but it was quite -- yes, it was fantastic, 20 to 360 to over 800.
And actually, one of the most important parts of that was the VTE section, where you go on to having a blood clot, which is obviously incredibly important to know. So I think overall, as you know, the NETs platform is extremely stable, now works on the Revvity machine, the point of care, which is fantastic on the pin prick with capillary blood. And I think now we have a very wide range of really potentially large uses for it beyond sepsis. And actually, we're working on another with a group in the U.S., which is exceptionally renowned as well. We could have a fourth very big use for it as well coming up in the short term as well.
So overall, the picture on NETs is really coming together between all those different conditions, and we're hoping that will lead to the big companies putting on their platforms and really trying to finish those discussions off with all these different uses.
Our next question comes from the line of Yi Chen with H.C. Wainwright.
This is Katie on for Yi. You guys have kind of described discussions with a good number of companies at various stages. Can you give us an idea of what -- how far those have progressed? Have they reached a contract negotiation stage, term sheet? And what's kind of a realistic deal structure for those? And I guess, what should we really be expecting from the next agreement?
Yes, very good question. So yes, we do have a lot of discussions going. And I think in the last quarter, it's actually expanded because a very large number we had. So I think it's fair to say a very large percentage of the large diagnostic companies and the liquid biopsy companies and a range of other companies. As you know, we have signed some deals already with Hologic, with Werfen and with Revvity, Revvity being the machine platform for the IVDR launch in Europe and the IVDD. And so that's gone extremely well.
The NETosis stage, I think it hinges on getting the big agreements with the big diagnostic companies. These are very large use cases really well fleshed out. And I think, as I said, I think we're getting there definitely on sepsis. Trauma has been a fantastic new entrant in the last quarter with the Mayo Clinic and then HS, as was mentioned. And as I said, we're also working on another very large use with a fantastic institution in the U.S. And then, of course, we have the Nu.Q Capture side, which interest has gone up tremendously since the paper was actually in preprint. And on the preprint side, just as a background, it's now being downloaded 2,700 times, which is quite obviously a huge amount of interest. And very fair to say a large amount of interest from a lot of groups on the capture side.
So yes, where we are with the different groups. All of them, obviously, we're having discussions with. The more advanced ones are going to the stage of technical validation and their own trials on different technologies and their own processes, and that's progressing well. And so we're very happy with how they're progressing. We're doing a lot of work with quite a few of them. The actual terms and the processes is confidential until we finish. But what we've said, and if you look at deals that have been done in this space, they typically involve upfront payments or milestones and a share of the revenue going forward, either through royalty or through some other process like the sale of key components.
So we don't update on each one individually. Obviously, there's confidentiality issues. But yes, we're very happy with how they're advancing. There's a lot of discussions going on, and we'll continue to update as they come through. But certainly, in the NETosis space and the Capture space and with groups like Revvity, Hologic, and Werfen, we've made fantastic progress, and we'll update you as they come through.
Great. If there's time, I'd like to have a quick follow-up on Werfen and Hologic.
Yes.
Could you quantify how -- what revenue has come in from those two so far this year? What kind of format it came in and kind of give us an idea of what conditions or triggers might produce more revenue from those deals for the rest of 2026, '27?
Yes, good question. So Werfen, we're working on APS. So basically, the NETs platform, as you know -- as you can tell from everything, can be used in a very, very wide range of areas from all the autoimmune diseases, sepsis, COVID, trauma, as we now know, and of course, things like sepsis syndrome. I mean, extremely wide range of uses. So what we've been working with different groups is getting them to either sign up for a big license for things like sepsis or for smaller uses, which then we hope to expand through other processes. So groups like Werfen, they're in the process of showing how well it works in that autoimmune disease as we also have HS on top of that, as you know.
So there was a small upfront payment, which we've made. Part of the contract, we don't disclose that, but they have paid an upfront payment and there are further payments being made from them, not of a large scale yet because they're still in the process of reviewing in APS, but we are working with them and other groups to broaden it beyond those first beachheads, if you will. Hologic has been working on a few agreements. We don't break down the different individual revenues. but they are working with us on selling some of the Discover portfolio. But also with them, we're looking at these as the first beachheads to expand it to other processes and other products. Companies like Hologic and Werfen and Revvity, where we have existing agreements, we are looking to really grow them through the process.
So the bigger agreements, which we're working on we expect to be coming with larger upfront payments and larger milestone payments. But the first ones we're kind of working through those early projects, working through with Revvity the launch in Europe, working with Hologic, so they can sell our range of Discover products. And the revenue from Discover, as you can probably tell, has gone extremely well and is growing strongly. We don't break out what comes from them, but it's going strongly as a group. And Werfen, they're working through APS now, and there was that initial payment. So both -- they're all kind of starter agreements. We're working to get big agreements with them and working on a very wide range of big agreements with the other companies. And we'll update the other ones and the upgrades as they come through.
Our next question comes from the line of Steven Ralston with Zacks.
My first question concerns the progress of the prospective clinical study at the Hospices Civils de Lyon. They placed their first commercial order for their internal validation process. How is that process going, and does Volition need to wait for the reimbursement dossier to be completed for an additional order? Or is there a possibility it could be an order through -- I understand there's funding through the MERRI G03 allocation process.
Okay. Well, Steven, I've not heard of the MERRI G, but we can come back to that. And so there's a couple of things that are still going on with the Lyon team. So firstly, from a clinical study point of view, they have a final clinical validation study that is called [ Ulysses MAP ], and that is ongoing. The recruitment has been completed and that study now just plays out because it's a longitudinal study. We hope to report that study later this year at ESMO 2026. So that's the clinical study. In terms of the certification of the product for use at the hospital, that has been completed. So that work has been completed. So there's no issues there.
In terms of the reimbursement, then from a reimbursement perspective, we have compiled and sent into the relevant authorities, a clinical compendium for their review that we've requested a pre-submission meeting. So we're now just awaiting with the team at Lyon and indeed a couple of other hospitals in France that are supporting the pre-submeeting for reimbursement. So a lot of work going on in the background, but we're kind of on track, I would say, at the moment for Nu.Q Lung Cancer.
Could you talk about the documentation that's being used to support the Nu.Q test in the new in vitro diagnostic requirements for the CE Mark?
So I don't have a lot of detail on that to hand, but just suffice to say that there is a team they worked on the IVDR submission. And all of the documentation has gone alongside that. We haven't yet published some of that information that's going to be used to support the IVDR application because I myself have sight of it today. But the submission for IVDR status is ahead of schedule in terms of our IVDR application, and we'll update you later in the year as that progresses.
And that's something which is obviously going to be very important for us, Steven, having -- moving from IVDD to IVDR. As we've talked about, there's a dozen hospital networks now are reviewing it for more than 20 different uses beyond those very big ones that we've mentioned many times, trauma, sepsis, HS, APS, they're working on a very wide range of different uses. So having that regulated products move from IVDD to IVDR is a very big point for us. And as Louise said, we're very happy with how it's going and I think it's ahead of schedule. So expect to see a lot more of that this year as well.
And lastly, I see the number of potential licensees, and discussions with them has gone up from 10 to 12 according to your latest press release. Could you talk about in general the pathway that leads these companies to initiate discussions with Volition? Is it the clinical papers? Or is it the symposiums or conferences that you attend with your posters and presentations? Or are there some other avenues? Or is it just a mixed bag?
It's interesting. Yes, it's a mixed bag. Some are inbound requests. Obviously, let's just talk about the Capture paper, for example. It's been downloaded 2,700 times now. So we've had some inbound interest. We've been in discussions with pretty much everyone for a while now on different things. So they've often got back to us but now they've seen the new data that's come through. On the Nu.Q NETs side, as we've come through with things like the Mayo paper, we've had a lot of discussions progressing, obviously, contact them with such a great institute having such great data in such a key area. We've had some very high level, very active discussions for a while, and as I said, negotiations going on.
So it's a mixture of people we know from -- we've been around a long time that we worked with, partners which have followed us in the space. Some have come through key opinion leaders like in Evangelos' case in the HS field. So some inbound, some outbound, some long-term relationships. Actually, it's 12, but there's actually a bunch more that have kind of semi-active that we've been working through that have become active. So yes, we're very happy there's been a pickup in all of that.
And I think also, I mean, the Cat paper is getting close to -- we're moving through the review process. So some vet people we've spoken to have contacted us again because of that. Sometimes and beyond the human space back into the vet space, obviously, some of our groups we're currently working with become interested in something new. So they ask, "can Capture work in cats or dogs?" So we get renewed interest like that kind of thing as well. So a bit of everything. All the things you said, we've got interest.
I think it's actually -- if you add up all the big players, it's pretty much everyone is interested at some level in liquid biopsy companies and large diagnostic companies and all the vet companies. So we're getting a lot of interest. We know now our job is not to get interest to close deals. So we're working on that very hard. But I have to say there's a big wave of interest coming as the publications get close. And for example, Capture paper is also working through the system. So that could be something which is out as well. And that's another reason to reinvigorate discussions when you actually have a published paper. So yes, we're happy with how it's going, and we'll have a lot more to talk about this year, we think.
Our next question comes from the line of Ilya Zubkov with Freedom Broker.
I have a question related to the launch of the rNuQ webshop. Could you provide more detail on your plans for developing this online channel going forward? And how should we think about the revenue contribution of this channel?
Yes, good question. So obviously, we have -- I think there's no doubt now we have a remarkable platform that's robust, reproduced, reliable. We have a lot of intellectual property. So that's all fascinating, but people want to see money. So how does that make revenue? So obviously, we spend all the time thinking beyond Nu.Q Discover, which is growing very well, and Vet, which is also growing and all the licensing deals, how can we make money with what we have. We've become the experts at chromatin fragments and what we do. To get those chromatin fragments on an ELISA, you need a control. As you know, we've been making recombinant nucleosomes for a long period of time, and we're working also on nucleosomes for sequencing. So we've become very, very good at making them.
So we do actually -- it's like a lot of things. It's usually worth making by quite a large amount of them in one batch, so beyond what we need them for. So we've had some inbound interest in the past for groups that need recombinant things for a whole lot of uses. They're useful in a very wide range of, like in Discover, we have 100 clients. People have said, we are making extremely good recombinant nucleosomes now. So we did a bit of a market analysis, and it's potentially quite a big market. So we thought let's make it available and easy for people who want to order it.
On the revenue side, I guess, Terig can say, short answer is we're not sure exactly how much the take-up is going to be. They're extremely useful to us. And I think potentially extremely useful to other groups. So in the interest of getting all the revenue can wherever we can, we thought it was worth setting up. The cost, obviously, was quite low in setting up a recombinant shop. And we'll be adding other things to it as well as we see how this go. We make a lot of different recombinant nucleosomes for our own research and processes. And I said, what we call Mustang, which are recombinants for sequencing as well, which is potentially a really big market.
So we'll see how it goes in the next few months. And I think there will be an interest, but we're not releasing projections now. And quite honestly, we're not exactly sure what the take-up is going to be, but we're hopeful because it is very useful, and it wasn't a lot of effort to make it out of the process. So in the interest of making as much chance of revenue as possible, we put it on the market. So we can update you over the coming quarters.
Our next question comes from the line of Bruce Jackson with StoneX.
A couple of questions on the vet space. So with the feline milestone, that goes to deferred revenue, correct? And have you received the $5 million payment yet?
You're right, Bruce, that goes -- that will, when we receive it, go to deferred revenue. We haven't received it yet. What we have done is we've submitted the paper, which is part of the milestone. And when that paper gets published, that's the completion from our end, at least of the -- of our milestone deliverables. And so after that, it will be a matter of time before we collect that. milestone payment. But you're right, when we initially collected, it would go to deferred revenue.
Okay. And then a question about the product revenue for the quarter. What portion of that was from the vet business?
We don't split out the individual pillars at this point. But what I can say is that we've continued to make progress in the product revenue sales. So we did see underlying growth there. As I mentioned in the earnings call itself, the big bump did come from deferred revenue, which we recognized $0.7 million of. And that was a result of us reviewing in line with our accounting policies, the revenue recognition and deciding that we recognize that a bit faster.
And then with that, is that kind of the rate going forward? Or is that kind of like a catch-up type of recognition?
Yes. So it's partly a catch-up and -- but the rate going forward will be a bit faster as well.
And we have reached the end of the question-and-answer session. I would like to turn the floor back to Cameron Reynolds for closing remarks.
So thank you all for coming on the call today. I hope it was a good review. And just to reiterate, we are working very hard on the commercialization side. We're in a lot of discussions, and we hope to have a lot of news on that throughout the year as well as on all the product developments and particularly in the Capture and the NETs space. So thank you very much for all your interest, and we look forward to catching up with you next quarter. Thanks for your time.
Thank you. This concludes today's conference, and you may disconnect your lines at this time. We thank you for your participation.
VolitionRX — Q4 2025 Earnings Call
1. Management Discussion
Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited Full Fiscal Year 2025 Earnings Call. [Operator Instructions] This conference call is being recorded today, April 1, 2026.
I would now like to turn the call over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.
Thank you, and welcome, everyone, to today's earnings conference call for VolitionRx Limited.
Before we begin, I'd like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance or achievements expressed or implied by these statements.
We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. We do not undertake an obligation to update any forward-looking statements made during the course of this call.
Cameron Reynolds, Group Chief Executive Officer, will open the call, providing a summary of key achievements in 2025. Terig Hughes, Chief Financial Officer, will then provide a financial report, before handing over to doctors Retter and Micallef, who will present research highlights from across our product pillars. Cameron will close with a discussion of upcoming milestones. We will then open the conference call to a question-and-answer session.
And with that, I'll turn the call over to Cameron.
Thanks, Lou, and thank you, everyone, for joining Volition's full fiscal 2025 earnings call today. As always, we very much appreciate your time given the busy earnings call season.
Before diving into detail, I would like to take a moment to reflect on our founding mission. We set off over 15 years ago to help save lives and improve outcomes for millions of patients worldwide. And I could not be prouder of the progress we have been making towards that goal.
In the fourth quarter of 2025, we not only received our first order for the new Nu.Q Cancer assays for clinical certification ahead of routine clinical use in lung cancer, but we also announced 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. Our tests are about to be used in both these devastating diseases to help save lives in the real-world hospital settings, an extremely proud moment for our entire team.
Cancer and sepsis are leading causes of death, accounting for approximately 1/3 of deaths worldwide. With the first clinical use now imminent, we're about to be part of the solution, through simple, easy-to-use, low-cost tests. I believe we will look back on 2025, this first quarter of '26 and, in time, the next few quarters, as transformational for the company.
In 2025, efforts for Volition focused on commercializing our groundbreaking Nu.Q platform in the human diagnostic market. We're excited to start the implementation of our human licensing strategy with the signing of not 1, but 2 agreements. The first, with antiphospholipid syndrome, APS, with Werfen; and a co-marketing service agreement with Hologic. Both are multibillion dollar companies and worldwide leaders in their specialized fields, and we are delighted to be working with them.
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. These discussions are at various stages of negotiation process across all our different pillars, and we anticipate announcing additional agreements throughout 2026. Our goal is to secure a wide range of licensing agreements in the human diagnostics space, mirroring our successful strategy in the vet market. And we anticipate diverse deal structures with potential for upfront and milestone payments and future recurring revenue.
We have developed a truly remarkable, versatile platform and are working with governments and some of the biggest diagnostic and liquid biopsy companies to make our technology available worldwide as quickly as possible.
Beyond licensing, we also achieved several significant commercial milestones in 2025. In the first quarter, we recorded our first revenue from sales of our CE-marked Nu.Q NETs automated assay, a regulated clinically approved product. NETs, or more specifically NETosis, goes far beyond just sepsis and is implicated in a very wide range of diseases. Currently, 12 hospital networks across a number of countries are evaluating our Nu.Q NETs assay across 15 different clinical use cases and indications. We believe NETs testing will become a key part of routine blood testing.
In February of 2025, we announced our first commercial sale of Volition's proprietary high-throughput NETs method that measures neutrophil extracellular traps, NETs, activation and inhibition in whole blood in real time, helping companies develop new therapeutics to combat sepsis and other NETs related disease.
In March, we signed an agreement with a leading pharmaceutical company to utilize Volition's Nu.Q Discover biomarkers in a longitudinal Phase I/IIb study, the first human clinical study with a pharmaceutical company sponsor that our test supports. Through our Nu.Q Discover pillar, we are now serving close to 100 clients worldwide, including many top pharma and diagnostic companies, accelerating disease research and drug development across multiple therapeutic areas. Some of these pharmaceutical companies are progressing to late-stage clinical trials using our assays as pharmacodynamic biomarkers. We estimate the total addressable market for relevant companion diagnostics to be a little under $1 billion. In 2025, we delivered substantial revenue growth for Nu.Q Discover, which Terig will detail. And we anticipate a similar trajectory in 2026.
The Nu.Q Vet cancer test is the #1 canine cancer screening blood test in the world, now available in over 20 countries.
To further accelerate revenue growth and ensure consistent delivery, we focused on central lab automation. In March of 2025, Fuji Film Vet Systems extended their contract to implement a centralized automated platform for the Nu.Q Vet cancer test using [ IDS i10 ] made by Revvity. Subsequent to year-end, in March of this year, we announced the completion of all validation and verification of the chemiluminescence immunoassay, CLIA, version of the Nu.Q Vet cancer test with Fuji Vet Systems in Japan, allowing use of full automation rather than our new plates in central labs. This is a world-first and will significantly enhance turnaround times and throughput to meet increasing demand.
We believe that central lab automation is crucial for scaling of our vet business and integrating our tests into routine pet wellness panels. Importantly, this automation platform is the same technology utilized for our human diagnostic products Nu.Q Cancer, Nu.Q NETs and Nu.Q Discover, highlighting the inherent synergy and efficiency of our core Nu.Q platform.
From a product expansion perspective, we made great progress with our research in the use of Nu.Q NETs in cats. In May of 2025, we announced the publication of our first clinical paper reporting the detection of nucleosomes in cats. And subsequent to year-end, in early January of this year, we reported results from a clinical study demonstrating the high accuracy of its Nu.Q Vet feline assay in detection of lymphoma in cats, the most common cancer in the species. At 100% specificity, meaning no false positives, the assay detected over 80% of feline lymphomas.
This breakthrough marks the development of what we expect to be the world's first simple, affordable blood-based liquid biopsy test for feline cancer, a significant unmet need in veterinary medicine. This opens up the potential for cancer screening and monitoring in cats. There are more than 60 million cats in the U.S. alone, 25% of which are senior cats and, therefore, suitable for an annual check. This represents a tremendous commercial opportunity for Volition.
The publication of this study in a peer-reviewed journal is expected subsequently to unlock a $5 million milestone contract payment. And we will also generate ongoing revenue in this large and growing market where our technology meets an unmet need, incredibly quick progress from a product development perspective and great to add a third species for Nu.Q.
I will return at the end of this call to discuss some additional recent achievements and upcoming milestones. But now we'll pass over to Terig for a finance report.
Thanks very much, Cameron, and hello, everyone. I'm now delighted to provide a full fiscal year financial report for the year to December 31, 2025.
From a revenue perspective, we finished the year strongly with year-on-year growth for Q4 of 133%. For the full year 2025, we recorded $1.7 million in revenue, a growth of 40% over the full year 2024. And I'm delighted to report we received our first revenue from the CE-marked Nu.Q NETs product in Europe during 2025. We also received our first order for Nu.Q Cancer from Lyon for the certification of our cancer test in their hospital network, more of which [indiscernible] later in the call.
As we have stated previously, at this early stage of commercialization, revenues remain fairly lumpy and difficult to predict from 1 quarter to the next. So while I remain confident of continuing to see solid growth year-over-year, we will not be providing revenue guidance for 2026 at this point in time.
From an expenditure perspective, we significantly reduced operating expenses, which were $4.8 million lower, a reduction of 17% compared to the full year 2024. And indeed, looking at the trend over the last 2 years, we are now operating at significantly lower levels of expenditure. Furthermore, we will continue to take measures to reduce costs further over the coming year.
Net cash used in operating activities was $19.7 million in 2025. This compared with $25.9 million in 2024. Cash and cash equivalents at the end of the year totaled approximately $1.1 million. However, subsequent to year-end and through March 25, we received approximately $5.4 million in net proceeds from our at-the-market or ATM facility, and $1.9 million in net proceeds from issuance of a convertible note to [ Lind ] Global Asset Management LLC. We continue to receive significant support from agencies of [ the Walloon region ] in Belgium. And subsequent to year-end, we announced nondilutive funding of approximately $2.3 million. This takes the nondilutive funding support from all sources from inception to date to over $25 million.
So to summarize the finance report, key indicators are trending positively. Revenue was up 40% year-on-year, operating expenses were down 17% on a full year 2025 basis, net cash used in operating activities was down 24% year-on-year. We continue to work on reducing our underlying operating expenses. We expect to secure a $5 million milestone payment from our existing agreement in the vet space. And last but not least, licensing discussions are progressing well, and I look forward to providing updates as they progress.
Throughout 2025 and indeed subsequent to year-end, we have made significant scientific and clinical progress. And so with that, I will hand over to Andy and Jake.
Thank you, Terig, and hello, everyone. I appreciate there is an incredible volume of information shared on these calls, so I will try and limit my comments to what I believe our recent important clinical achievements. I'll start with Nu.Q NETs.
NETosis is an area of increasing scientific interest with a significant number of research articles published in recent years. In February, a review article entitled "The NETs Effect [indiscernible] Trap: A Potential Key Component of this Regulated [indiscernible] New Response" was written by myself alongside 2 key opinion leaders in the sepsis arena, Professor [indiscernible] and Professor [ Marvin Singer ]. This paper has already been accessed more than 11,000 times and cited in almost 60 peer-reviewed publications.
From a clinical utility perspective, we have published 2 key papers. The first was with the team from [ UMC ] Amsterdam, looking at more than 1,700 critically-ill patients. Our paper is available free to download from Critical Care. The second paper, available on Med Archive, written with our colleagues in [ Jena ], is another independent study looking at 971 patients with sepsis. Together, the data from these studies show that Nu.Q H3.1 accurately distinguishes sepsis from noninfectious systemic information. It is strongly correlated with disease severity and provides excellent prognostic information for outcomes such as organ failure, specifically renal failure, and mortality.
The prognostic power of H3.1 measured at ICO admission significantly exceeded existing severity scores, such as Apache II and the [indiscernible] score.
As a result of this convincing evidence, in December, we were delighted to announce the inclusion of our Nu.Q NETs test as the sole biomarker in the DETECSEPS study, a real-world evaluation using H3.1 in combination with the National Early Warning Score to promote the early detection of sepsis and try and promote the flow of patients for emergency rooms. This is a problem every health care system in the world faces.
Not only is DETECSEPS led by prominent clinicians, it's also backed through financing from the French government. DETECSEPS aligns with Volition core purpose of operationalizing our understanding of [ AP ] genetics and in particular of H3.1 in clinical practice to help identify and monitor the severity of disease. The DETECSEPS program provides an opportunity to receive individualized care adjusted to the risk of deterioration or risk of progression to multiple organ failure. It is a great privilege to be involved in such a program. And we hope that through earlier identification and risk stratification of patients, many lives can be saved.
We also hope that by improving the flow of patients out to the emergency rooms, that we can help hospitals run more efficiently, sending people home safely, escalating and expediting care to those patients who need it most. These efficiency gains could be huge and have a real impact on the entire running of hospitals and improve the delivery of health care. I think you can understand why we say it has an impact in all health care settings.
Our final exciting development in 2025 has the potential to be a game-changing technology not only in disease where time is critical for sepsis, but also in providing our tests to lower-income countries where laboratory infrastructure may be weak or inexistent. Specifically, this is the development of a lateral flow test for point-of-care quantification of nucleosomes. In July 2025, we reported the quantification of nucleosomes in whole blood in minutes utilizing a simple lateral flow device. I'm delighted to say the second phase of research is now well underway, with the first patient recruited for comparison between whole blood and capillary blood in critically-ill patients. This really is a technology to look out for in the coming months.
And hot off the press, we are delighted to announce this week the publication of a study with our colleagues at the Mayo Clinic in the journal [ Shock ]. The Mayo Clinic site of 674 trauma patients demonstrated that nucleosome levels, as measured by Volition's Nu.Q H3.1 and Nu.Q H38 citralene tests are elevated in people that go on to have complications from trauma. The identification of reliable biomarkers in trauma is a clinical challenge and remains a significant unmet need in emergency and surgical settings.
Professor Park, the principal investigator and senior author of the paper said, "These biomarkers could aid in early risk identification and may inform targeted preventive strategies in trauma care." For my part, I believe this is a significant study not only for clinicians, patients and their families, but also for Volition. A peer-reviewed publication with the Mayo Clinic Research team strongly support our efforts to commercialize our Nu.Q NETs products. Indeed, our overall sentiment is that this study, together with our previously published [indiscernible], demonstrates that Nu.Q NETs may enable clinicians and researchers to anticipate disease, guide treatment decisions, understand disease trajectory and monitor patients over time across acute and chronic conditions.
Turning to Nu.Q Cancer and, in particular, lung cancer, where the first clinical use of Nu.Q is now imminent. Nu.Q Cancer represents a significant advancement in lung cancer patient management, offering clinicians an additional tool to enhance precision and treatment selection and monitoring. Research conducted by our long-term collaborators in Taiwan and Lyon consistently demonstrates that our Nu.Q Cancer technology empowers clinicians to make informed treatment decisions that provide valuable new monitoring capabilities through the patient journey.
From a publications perspective, the first MTU manuscript was published in March 2025. Coincidentally, almost the same day as the first patient was enrolled in the validation study. The MTU team also presented data at the North American Lung Cancer Conference in Chicago in December. And then as recently as last week's ESMO's European Lung Cancer Congress. Both posters support the use of Nu.Q Cancer preemptively to help identify patients at high risk.
High H3K27 [indiscernible] nucleosome levels predicted poorer recurrence-free and overall survival outcome. Whereas a lower H3K27 trimethyl level indicated a significantly better outcome. Joint Lead Author, Dr. Chen, commented that "The Nu.Q Cancer technology supports a practical approach to empower clinicians to make a more informed treatment decision and provide valuable new monitoring capabilities throughout the patient journey." This is excellent endorsement indeed. And I know from the commercial team that they are now looking forward to how we can provide the test in routine clinical practice.
Together with our colleagues in Lyon, we've also presented at a number of conferences, have prepared a further 2 manuscripts for submission peer review publication, the first of which has just been submitted and the second is due to be submitted in the coming weeks. These results demonstrate that measured methylate [indiscernible] biomarkers at non-small cell lung cancer diagnosis can provide value information about survival -- progression-free survival and crucially help enhance the identification of patients who may benefit from more intensive therapy and potentially offer them curative care.
As Cameron said at the top of the call, we made our first sale of our Nu.Q Cancer assays to the [ Hospice d'Lyon ], one of Europe's leading cancer centers. And subsequent to year-end, we have announced, with the support of our Lyon team, the preparation of our reimbursement submission to the French government.
Reimbursement is the next step on the path to the first use of Nu.Q in clinical practice, an exciting prospect which is core to Volition's mission using our test to help save lives. The investment will be a major milestone for Volition in the commercialization and licensing of Nu.Q Cancer. Once achieved, we anticipate the introduction into routine clinical use in France by fourth quarter of 2026. This is a truly exciting and rewarding prospect.
And with that, I will pass you over to Jake, who will give you an update on another significant project. Thank you, everyone. Over to you, Jake.
Thanks very much, Andy, and hello, everyone. I'm just going to be talking about 1 project today, Capture-Seq, which we've had several announcements about, the first in December and others in more recent weeks. Volition is, I believe, the first company to demonstrate the isolation and analysis of greater-than-99% pure circulating tumor-derived DNA.
To set the scene, the biggest problem facing liquid biopsy worldwide is that the vast majority of circulating DNA in blood plasma samples comes from healthy cells, not from cancer cells. In a world-first new technology, Volition has overcome this hurdle and produced greater than 99% pure cancer-derived plasma DNA sequence set for liquid biopsy. Our manuscript, submitted in November and previously announced in December 2025, described a new liquid biopsy chemistry for isolating CTCF DNA from plasma. Subsequently, our continuing work on CTCF-bound DNA has revealed what we believe to be an unprecedented new discovery, but there is almost no CTCF-bound DNA in healthy plasma and almost all CTCF-bound DNA in the blood of a cancer patient is derived from cancer cells, i.e., it is virtually pure circulating tumor-derived DNA.
Removal of background normal cell-free DNA from the blood to reveal this level of tumor-derived DNA has been a long-term goal of liquid biopsy. In this updated manuscript, we report a new 2-step method for preparing virtually pure circulating tumor DNA set for cancer patients.
The first step is the physical enrichment of the sample. And the second step is the [ bioenmatic ] removal of virtually all remaining nontumor cfDNA sequences from the DNA sequence data set. This new method produced more than 99% pure ctDNA sequencing data sets for blood samples from cancer patients. And whilst we capture a subset of the circulating tumor DNA, not all of the circulating tumor DNA in a sample, it is virtually pure cancer DNA.
These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers, representing, in my opinion, the best scientific breakthrough in cancer testing and monitoring in recent years.
Last week, we released data from a blinded validation cohort of 81 subjects, including 59 colorectal and lung cancer patients and 22 healthy controls. And we were extremely encouraged by the results, particularly in early-stage cancer where we detected more than 95% of Stage 1 and Stage 2 cancers.
For patients, the potential significance is huge. If validated in larger cohorts CTCF Capture-Seq could contribute to multi-cancer early detection, fulfilling a significant unmet clinical need. We also believe Capture-Seq has the potential to play a role in cancer management, including but not limited to, minimal residual disease detection, including tumor-naive minimal residual disease detection and treatment monitoring, either alone or potentially in combination with other technologies.
Volition is, I believe, the first liquid biopsy company to focus on circulating cell-free nuclear proteins, and we have filed a number of new patents to protect this technology. As you can imagine, this has generated a lot of interest and we're in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development and launch of this technology as soon as possible.
And with that, I'll pass over to Cameron for his commercial perspective and wrap-up. Cameron?
Thanks, Jake. Let me start by congratulating you, Andy, and the whole innovation, research and development and the clinical teams on the truly amazing progress you have made, not only this year but over the last 15 years. We set out to help save lives and improve outcomes for millions of patients worldwide, and we're making huge progress towards that goal.
With the first clinical use now imminent in both early sepsis detection and lung cancer management, we are about to be part of the solution through simple, easy-to-use, low-cost tests. Our vision is for our technologies to be incorporated into tests that will be used first by millions and, ultimately, hundreds of millions of people and animals a year, with our platform license to a range of large diagnostics and liquid biopsy companies and governments worldwide.
Combining our groundbreaking technology with their installed base of labs, analyzer machines and sales forces around the world, we will achieve the optimal outcome for us. Large companies have the resources to realize the opportunities better than Volition.
The total addressable markets, TAMs, for our technologies on an annualized basis are multibillion door opportunities, not only for Volition, but for our licensing partners too. Volition has made strong progress both clinically and commercially. Our goal is to secure a wide range of licensing agreements in the human diagnostics space, mirroring our successful strategy in the vet market, and anticipate, similar to vet market, diverse deal structures with potential for upfront and milestone payments and recurring revenue.
As mentioned earlier, we are continuing our discussions with around 10 of the world's leading diagnostic and liquid biopsy companies. These discussions are at various stages of the negotiation process across all our pillars. Our laser focus is on executing licensing agreements and we will update you as they complete.
Thank you for joining our call today. We very much appreciate it. We will now take your questions. Operator?
[Operator Instructions] Our first question is from Justin Walsh with JonesTrading.
2. Question Answer
As we see more from Capture-Seq, it would be great if you could provide some additional color on the current state of the liquid biopsy field, where maybe the field has seen some success and where alternative approaches have fallen short. And then maybe related to this, some takeaways on the failure of the large NHS GALLERY trial to achieve its primary end point.
Yes. So we tend not to criticize the other companies. I mean they're often well-run companies with good people trying to do good things. But I think it's very fair to say our discussions with everyone, no one out there is very -- since their current testing modality is where they really needed to be in early-stage detection for multi-cancer detection, or an MID for treatment naive, that's obviously not something either, so there is 100% an opportunity for anyone who can develop something which is truly routine, which ours is, low cost and easy to use, which ours is. And it certainly appears to be very accurate. We're doing more and more study, but the early work is incredibly encouraging.
So I think in any space like cancer detection, there's going to be a number of parties. No company, no matter how good the technology, will be everything. But I think there's a very strong case to be made we will be a big part of cancer detection in the human space, like we are in the vet space, starting with the fantastic lung work, which is in the process of being reimbursed, which is incredibly encouraging. And of course, the strong promise we have from [indiscernible] capture, which could either be used in conjunction with what's currently used or potentially a test in itself. And given the early stage detection that we've shown, that's certainly a possibility.
So overall, I think we've got something which is very special in what we do. And we're working with a number of groups now. Obviously, we can't say who they are. It's confidential. But we have a lot of active discussions ongoing. These are things which are far bigger than we can commercialize ourselves. And the bigger companies certainly have the installed capacity or the knowledge in particular areas like screening and MID. So we'll be updating as those hopefully come to fruition, hopefully, in the near term. And we're expecting a lot of news on that through the year.
But as far as individual ones go, I guess, I read the news, there's been a lot of things which have not turned out exactly how they wanted. But we always say, we will succeed if we deliver a good platform. So we haven't spent a lot of time concerned about everybody else. There's always going to be a place for a routine, accurate low-cost test. And that's exactly what we think we've developed. So we're working hard on commercializing.
Our next question is from Yi Chen with H.C. Wainwright. .
My first question is, could you comment on how do you expect the Nu.Q Cancer assays to ramp up in terms of volume throughout 2026? And my second question is, can you just provide some general comments on how many new licensing deals you expect to close this year?
I'll start with the deals. And the first question, I didn't quite understand, what -- so can you repeat the first question, please?
How do you expect the volume of the Nu.Q Cancer assays to ramp up through 2026?
Okay. I'll have the CFO to answer that. I'll do the deals. Look, it's very hard to know. We've signed several in the human space already with fantastic companies. We're working with 3 multibillion-dollar companies in the human space now. Revvity has launched a CE-marked kit in Europe on its platform. Revvity via PerkinElmer, obviously, a very large company. They very much like what we do.
We're working with Hologic on the Discover side, on the marketing, which is very exciting. And we're working with Werfen now on the NETs kit and the process. So if you look at each individual area, I think, ultimately, the NETs test will be something that's extremely widely used. And the uses, as we've said, go way beyond the massive market of sepsis. Just yesterday, I believe, it was yesterday, anyway, these last few days, we announced the Mayo Clinic results, which show, if you had trauma, a very elevated level -- I mean I looked at the numbers, it's quite spectacular, very elevated level if you've had trauma, and even higher, and I mean, very, very high. You can go through the numbers again in the paper, if you've had VET. And trauma is one of the biggest -- well, highest cause of death of people below 50 in the world and one of the major causes of admission to emergencies. So another massive use for our NETs test.
So deal wise, there's all the NETs tests. We're talking with more companies now on the capture side, which is obviously very exciting. The governments are working on the lung cancer monitoring side, as you know. So it's hard to say which of the 10 or so companies will be first and what the order will and how many there will be. But I think I strongly suggest we will have multiple deals with different companies, different governments this year. And I think it will be across cancer and probably NETs as well.
And then we're also working with groups on our recombinant nucleosomes and on Discover. And don't forget, we do have 100 clients in Nu.Q Discover now, and some of those are coming to the stage where they're going to become quite large in process where they come into clinical studies where they become very serious amounts of revenue.
So overall, I can't give you an exact number, but I'm sure I'm quite certain we'll have deals. And we're trying to get them out as quickly as possible because we basically stopped the R&D side and we're now on just commercialization because we have an absolute mountain of opportunities in all of the pillars. And we're very happy with how those deals are progressing. And the volume, Terig?
Yes. So I think as Cameron mentioned earlier, we're in the process of submission preparation for the reimbursement. Yes, that's, obviously, that's an H2 event in terms of approval of that. And so we'd expect it to be about Q4 by the time we get reimbursed product into routine clinical use. So we haven't built a huge amount in this year given the timing, but we would expect it to ramp fairly quickly once it's in routine clinical use.
And the Nu.Q NETs now is in IVDD, in the process of being IVDR, so we're recording some revenue for that. But at the moment, we're not providing guidance, to be conservative. Obviously, there's a lot of things happening and they're all moving forward. But exactly when in the year it happens, obviously, will greatly affect when [indiscernible] recurring revenue. But they're all making progress, and they'll all be coming on stream, we think, in the next few quarters.
Our next question is from Steven Ralston with Zacks.
I looked into the revenue streams that you expect from the different pillars going forward, and it seems to be quite complex because there are different avenues in each area. [indiscernible] Nu.Q Vet is developed and it's basically dependent on the partners and how successful they are in their different geographic regions. Can you make a comment on the rate of acceptance of the vet test for canines among the different partners you have? And are there any commonalities of the more successful ones of how they've ramped up usage?
Yes. So I think there's several different partners there. I think -- so between all of them, the one strong message we got -- so obviously, our revenue is growing, but which in a normal company, 40% will be very good. But obviously, we're looking for a lot more than that to really ramp.
The key message from all of them, the key to that is to have it in a centralized lab. Currently, the vast majority of market, like over 80% of testing [indiscernible] is done through a centralized lab. The only option currently we have available in centralized lab up until few weeks ago was microtiter plate, the plastic plates. So obviously, that's not great if you're trying to do millions of tests. A centralized hospital network, and there are several in the U.S. and [indiscernible] you could get hundreds of thousands or millions of tests per network if it's part of a wellness panel or what they call the index [indiscernible]. We obviously have not tracked them yet. And a key part of that is the acceptance, but also being able to run maybe potentially hundreds of thousands of tests per month.
So you've probably noticed Fuji, who have been fantastic partners and very proactive, have shown it now works on the centralized lab. The fantastic Revvity machine, which we're now using also for NETosis in Europe, the CE-marked machine, the same one. So that will start flowing through.
So it comes down to -- it's lumpy between quarter-on-quarter and when they order that and when they don't, because the plates can last up to a year. Obviously, [ Antech ] has also launched the small machine, but that's also subject to them selling and getting those machines in lots of different places. So that's not going to be an exponential growth by any means. So it has come down to that.
But don't forget also, we are now working on felines, which potentially, I don't think will actually double the market. But theoretically, it doubles the market because there's more cats than dogs in the world, and that's making good progress. And obviously, we've got Nu.Q Capture, which potentially has uses in all this as well.
So there's a lot of things going on in vet, and it's very hard to predict once -- if and when a centralized lab system in the U.S. goes for the centralized machine, I think that's something that could then accelerate very quickly. But in the meantime, it's kind of lumpy and bumping along the rates of growth you can see. So it's hard to tell.
But our commercialization efforts in the last 6 months are very much focused on the human space. We're extremely keen, long reimbursement in Europe, that's EUR 50 per test. That's a lot more processed as well. And if it's -- once it's approved, we expect it to be by the end of this year, then obviously, that's a very good revenue source. And the CE-marked kits are out there, so we spent a lot of effort changing from IVDD to IVDR, so it extends indefinitely from the time [indiscernible] we currently have. And of course, we've put a lot of effort into licensing Nu.Q Capture.
So the vet has not been the focus of the company, but it's obviously important to keep it ticking over. But we have made progress in the cats and the centralized labs, and we're looking perhaps even for the transcription factors in dogs and cats.
How you even went into an area that I wanted to ask you about next, is that in Europe, you seem to have a very strong foothold with these hospital networks in the areas of sepsis and lung cancer.
Yes.
Is that a model for the -- for your global emphasis? Or it just happens to be that this is the first foray?
A bit of everything. So ultimately, what we have in Europe is a fantastic large multinational company in Revvity, so PerkinElmer, who have the machine which our test works on very well. They've undertaken to put it in lots of different locations. There's over a dozen large hospital networks, which are testing. So our CE-marked is any NETs related inflammation. So that's obviously a lot of different things.
You've seen the Mayo Clinic, that also involves trauma, and trauma is potentially as big as everything else. It's quite remarkable how versatile it is. But as Volition, we don't want to be doing 10 studies in trauma, in sepsis, in COVID, in APS, in HS, all those things. So we've shifted a lot to our partners doing the work, like Werfen, for example, in [indiscernible] diseases, it's like all the companies doing it in the process. So we are also looking for a large or several large diagnostic companies to -- who are like the diagnostic companies are, to take it on. And I think as Andy said, the evidence is getting more and more overwhelming that NETs is going to be a very, very, very large products. So if you take all the issues in sepsis, all the issues in all the autoimmune diseases, add in trauma and COVID, it's just obviously huge.
So it's been part of our strategy to get other people to buy our kits and do these studies, get [indiscernible] just their own time, but we're not spending. But I think that the big daddy of all those is the French government, which has spent [indiscernible] million, whatever it is, on an interventional study to test and hopefully launch our product as the screening test in France [indiscernible] in conjunction with [indiscernible] which are the physical symptoms, the biomarkers. If that does go well, and I think there's a very good chance it will, we won't know till the end, but we've seen it work very well in sepsis, we will become the test in France, which I think then will become the test in Europe. And then it becomes extremely easy to license to a large international diagnostics to do a 510(k) in the U.S. to also launch there.
So our strategy has been develop the platform, make sure it's [indiscernible] reliable, make sure it's certified, which it is now in the first platform, get other people to do the work. And I think that's been a tremendous success. And to get them to do the leg work to show what the [indiscernible] would be. So it fits in with [indiscernible] strategy, and now we're working with the big diagnostic companies to get the first one of them to license on large auto analyzing machines beyond the Revvity machine that we have now. Does that answer your question, Steven?
Oh, yes, very much so.
Yes. And just on a personal note, just to finish, I think it's incredibly gratifying. I don't know if everyone understands necessarily an interventional study means it's used on real people in real life, and those decisions are taken based on our test, that's going to be this year when the study starts. So that's -- the confidence they have in the test, this is not a university exercise or someone doing some samples from the freezer. It's an interventional study, and I don't quite know how much that would cost in the U.S., we didn't get it costed, but it's an awful lot more than the $8 million I think the French government is spending on it, to do it, say, in the U.S. So a huge amount of very valuable work being done for us, and it shows the level of confidence in what we do. And it's very heartening for us as a team to have them being used on actual -- saving people's lives this year.
Our next question is from Bruce Jackson with the Benchmark Company.
I wanted to follow up on the Capture-Seq -- it's a fabulous study. I'm curious to know how amenable is this process to front-end automation in the lab and how easily could it be integrated into like an MRD test or a liquid biopsy test in the lab?
Our objectives here [indiscernible] so that's probably a Jake question. Jake?
Bruce, thanks for the question. Yes, very good question. Essentially -- well, first of all, exactly how it works and how we've proved that we really have produced pure tumor DNA, all of that's in the paper and publicly accessible to everybody.
In terms of the question, the basic process involves 2 parts. So the first part is a magnetic antibody. So it's the same as an immunoassay, it's the same as a Nu.Q immunoassay, it's the same as a PSA assay or a [ CTA ] assay. And the second part is sequencing.
So immunoassay is easy to automate and the sequencing is actually much less involved than the sequencing that is involved in other tests, because we've removed all the background, so there's actually less DNA to sequence. And of course, there's, in the end, there's less analysis because most of the analysis is involved in trying to work out whether any of the DNA came from a cancer or not. But if you've removed everything that didn't come from a DNA, that analysis also becomes like a PSA test. It shouldn't be there. If it is there, it came from the cancer.
So I think it's, at the moment, what we do is manual, but it is extremely suitable to be automated.
And just some indications of costs, Bruce, people ask us this. It's -- we can answer that in a couple of ways. So the capture side, which as Jake said, the magnetic B, the antibody, the immunoassay, at the moment, may cost us $100, but that's going to come down, but not to $10 or $20, but somewhere more like $60, $70, $80 or something like that, to do the capture side. Then as Jake said, it depends on the sequencing.
Those sequencing really depends on what the panel looks like, how many markets you have. But that could be a few hundred dollars or $500, depending on where we end up and how the panel looks. But that's sort of the cost you're looking at for the test, sort of $80 if for the capture and then the sequencing. If it's shallow sequencing or [indiscernible] sequencing, shallow sequencing, it won't be a lot, but that's really to be determined.
And that's actually something our partners are looking at when we're looking at licensing. Obviously, they're the sequencing experts. So it's not a low-cost test [indiscernible] it costs us $1 or $2 to make, but it has a strong potential to be tissue-specific and very accurate. So I think the market certainly would bear a few hundred dollars for that test as we talked about. But that's all in process.
But no, it's incredibly encouraging and an amazing breakthrough for a small company to have managed to concentrate. And people say, how did we do it? What made us able to do it? We're the experts of chromatin fragments, CTCF fragments. Everyone has ignored the ultra-short DNA for a whole lot of reasons, the sequencing machines don't tend to do much below 100. And we're experts at nucleosomes and are experts at [indiscernible] bound DNA. So we've really done something -- 15 years of heartache and pain getting where we are, had made us very good at [indiscernible] and fragments, and this is just another [indiscernible] in fragments.
So it is actually quite easy process. It's a magnetic [indiscernible] antibody and sequencing. Obviously, there's a lot of sequence in there and a lot of work to get to where we are. But at its heart, it's a very simple process, which I think can be optimized a lot from where we are.
Okay. Great. Then just a couple of quick finance questions. What's the anticipated timing of the feline cancer milestone? I know the paper has to be published before you get the milestone, but would that be like a second quarter event potentially, third quarter?
So it's difficult to predict, but we do expect to collect that money this year. We are in the process of submitting that paper, which is the final step in completing the requirements for the milestones. So we do expect to have that completed shortly. And then it's, like I said, it's difficult to know exactly which quarter it's going to fall into in terms of collecting that money. But we certainly expect to collect it this year.
Okay. And then last question for me on the operating expense profile for 2026. Would you expect that to be up, down or about the same as 2025?
So I think we've made a lot of progress over the last 18 months in terms of bringing the costs down. We're now operating at a significantly lower churn rate than we were 18 months ago, for example. Nevertheless, we're continuing with cost-saving actions, and we're targeting take out another 25% to 30% from the cash OpEx this year. That's not all going to happen in one fell swoop. That's going to take us through the end of the year to achieve that so that the exit run rate is that much lower.
I think in terms of quarters, it's a bit lumpy and difficult to predict. But I wouldn't expect a sequential reduction in the first quarter. First quarter is always a little bit heavier and there are obviously some severance costs to take into account. So I think I would expect going through the rest of the year to see the cash OpEx burn rate coming down. Again, yes, it's not a one -- you won't see one big drop. It's going to continue to come down over the quarters over the rest of the year.
And I think, Bruce, something just to say from a more of a -- take a step back, we are obviously cutting because we understand [indiscernible] and we understand [indiscernible] and we need to cut. But also it's a fundamental shift in the company. We spent a lot of our time and effort on studies, on research, on papers and processes, which we're just not doing anymore to anywhere near the extent that we were. Because, as you said, the French government is funding the interventional study in sepsis. Mayo Clinic did a lot of that work, obviously, in the trauma and it's publishing itself. All those groups, Revvity selling kits to in Europe, are on the whole paying for the kits. And so we're not funding those studies.
So overall, it's coming down a lot because we are no longer spending on our data and R&D, we're commercializing. And I think we have an absolute pile of products, which I think [indiscernible] commercialize now. So we're shifting the cost base down quite a few notches so that we can, A, extend the runway, but B, it's just a fundamental change in our business. We are not intending to do a lot of research studies anymore. We're firmly in the commercialization path.
We have reached the end of our question-and-answer session. I would like to turn the conference back over to Cameron for closing remarks.
Thank you, everyone, for listening. I know it's been a very interesting year for Volition. And obviously, we've made a tremendous amount of progress. It's been a tough year in a lot of ways, as you can probably tell, but something where we -- I think we've made very strong progress in a lot of areas. And I can assure you, we're absolutely focused on getting products commercialized now.
So hopefully, we'll have a lot of news on that through the rest of this year and we can really turn the corner on the commercial side to be a strong commercial company, where we've been a very strong R&D and IP company. So keep a close eye at, we should have a lot of news throughout the year. Thanks again for calling in. Bye.
Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.
VolitionRX — Q4 2025 Earnings Call
VolitionRX — Q3 2025 Earnings Call
1. Management Discussion
Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited Third Quarter 2025 Earnings Conference Call. [Operator Instructions] This conference is being recorded today, November 14, 2025.
I would now like to turn the conference over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.
Thank you, and welcome, everyone, to today's earnings conference call for VolitionRx, Limited. Before we begin, I'd like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties and assumptions.
Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results performance or achievements expressed or implied by these statements. We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. We do not undertake an obligation to update any forward-looking statements made during the course of this call.
Cameron Reynolds Group Chief Executive Officer, will open the call providing a business update. Dr. Jake Micallef, our Chief Scientific Officer, will present research highlights from across our product pillars. Terry Hughes, our Chief Financial Officer, will then provide a financial report before handing back to Cameron to close with a discussion of upcoming milestones. We will then open the conference call to a question-and-answer session. And with that, I'll turn the call over to Cameron.
Thanks, Lou, and thank you, everyone, for joining Volition Third Quarter 2025 Earnings Call today. We very much appreciate your time, given the busy earnings season. 2025 efforts for Volition have focused on commercializing our groundbreaking Nu.Q platform in the human diagnostic market, -- and we were excited this quarter to sign not 1, but 2 agreements: a research license and exclusive commercial option rights agreement for antiphospholipid syndrome, APS, with Werfen and a co-marketing and service agreement with Hologic.
Both are multibillion-dollar companies and worldwide leaders in their specialized fields, and we are delighted to report that both have very much hit the ground running. Now taking each in turn. Worten is a global leader in the field of in vitro diagnostics for hemostasis and thrombosis among others, where neutral extracellular traps, nets play such an important role. And of course, we have the only approved test to measure Net. So this agreement fits extremely well into our strategy of leveraging the installed base of machines specific disease knowledge and customer reach of our partners, combined with our unique Net platform.
Under this agreement, Werfen will gain access to the components of Velition's proprietary Nu.Q [indiscernible] and will investigate its clinical utility in the management of APS patients on its platforms. Worten also has an option to negotiate terms with volition for it to launch the product commercially under an exclusive license. We have already successfully transferred the Nu.Q Net assay through their ACL ASTar platform. Early results in net levels detection in APS patients with the Nu.Q tests are encouraging. Werfen are excited to validate further and complete a clinical utility study to determine the potential role of this market as a risk indicator of thrombosis in APS patients, allowing a better management of this very complex syndrome.
This could open the possibility to enlarge Rofin's portfolio in APS testing. Just to provide a bit of background about the condition, as we haven't previously discussed this in detail, APS is a complex disorder of the autoimmune system affecting around 4 million people worldwide. It causes increased risk of blood clots and their associated complications such as stroke, heart attack, pulmonary embolism or deep vein thrombosis. It is also associated with the recurrent miscarriages and pregnancy complications. It is currently diagnosed through a panel of blood tests, requiring 2 positive results at least 12 weeks apart and is often a lifelong condition requiring regular monitoring.
Emerging evidence suggests increased net formation appears to be a central mechanism in thrombosis in APS and that targeting net pathways could provide future therapeutic avenues for thrombotic complications. We believe that Billiton's Nu.Q test is the first CV IVD assay being investigated in APS and could provide not only improved diagnostic information to aid clinical decision-making and personalized care, but also a low-cost test to continue to monitor these patients throughout their lifetimes. APS diagnosis and monitoring represents a total addressable market of approximately $85 million annually. So it is a very good early target for our NET platform.
It is exciting to achieve this major milestone with Werfen and we are already working with them on study design, et cetera. The second agreement we announced this quarter is with Hologic Diageo for the co-marketing of Volition newCDiscover service. The Nu.Q Discover service provides drug developers and find us with a range of state-of-the-art assays for rapid epigenetic profiling in disease model development, preclinical testing and clinical studies from discovery to being market-ready. Hologic has extensive experience, recording revenues of over $4 billion in 2024 from a large client base and international reach. providing tools to biotech and pharma companies and also to academic and government organizations.
We have seen strong growth in interest from our new Discover services and believe this partnership with Hologic will further accelerate the expansion of Nu.Q services to a wider base of customers to drive revenue. The inclusion of our new custom-based biomarkers in Hologic's portfolio demonstrates a strong validation of their value in clinical development. The Hologic team have really hit the ground running and have already presented the Nu.Q Discover offering at several international conferences, have launched a digital marketing campaign, including e-mails and LinkedIn advertising and have a webinar plan for next quarter.
They have also received a lot of inbound interest from existing customers, so definitely an exciting start to what we hope will be a long and fruitful relationship. We are continuing our discussions with around 10 of the world's leading diagnostic and liquid biopsy companies and are at various stages of this process across our different pillars, ranging from due diligence to tech transfer to evaluation of clinical samples to term sheet and contract negotiations. We are very confident of further licensing deals with a range of large companies and will update on progress as they are completed.
We believe that our positive emerging clinical evidence supports the broad applicability of our Nu.Q technology in critical areas such as cancer and sepsis, including as our biomarker of interest to epigenetic drug development and expanding area of focus for Big Pharma. Beyond licensing, as discussed on our previous calls, another prong of our Nu.Q commercialization strategy is to leverage our granted the mark approved in the EU for any nytosis-related diseases with the product under valuation in 14 hospitals in 5 European countries. As Dr. Andrew Retter has discussed on previous calls, nets implicated in a wide range of diseases.
We anticipate the presentation and publication of results regarding the clinical utility of the Niteroi assay across a range of diseases in the coming months and quarters. So please keep an eye up. In fact, we have made significant progress on several publications in recent months and anticipate peer-reviewed publications across all pillars in the coming quarters. One such paper just recently submitted for peer review, concerns our groundbreaking capture SEEQ technology. We believe the ability to concentrate chromatin fragments and therefore, tumor DNA has the potential to be a game changer in the liquid biopsy field.
It is an exciting prospect from a licensing perspective, and I am pleased to report that we are currently in active discussions with third parties. But to provide more detail, I'm delighted to pass over to Dr. Jake Malouf, our Chief Science Officer, to share a more thorough update on scientific and clinical progress. [indiscernible]?
Thanks very much, Cameron, and good morning, everyone. I'd like to start by providing a little more color and detail to the Capture project. We've recently submitted a paper on this describing an entirely new liquid biopsy method to analyze blood samples to find DNA from cancer cells. This is not a new way to target the same cancer-derived targeted by other tests. Instead, we target an entirely new class of cancer-derived DNA. This represents an entirely new class of cancer biomarkers with hundreds or possibly thousands of new targets all of which are ignored by current methods.
We have isolated this previously ignored DNA from blood and remove the background DNA. This is important because background DNA is the single biggest problem in current liquid biopsy methods, and nobody has ever previously managed to remove this background. However, our new method isolates just the DNA we are looking at with 180-fold concentration. That's an 18,000 enrichment and removes more than 99.5% and or almost all of the background DNA. This is a great result, but it would be easy to throw away the baby with the bath water. That didn't happen, we retained 48% of the target material for analysis with almost all the background DNA removed. This is the first. It's never previously been achieved in liquid biopsy.
Our new capture set method is extremely exciting. And I personally believe it may become commonly used worldwide, both in the detection of cancer and in cancer patient management. The focus of the paper we've submitted is scientific rather than clinical and showcases what we believe is a revolutionary new liquid biopsy method for detecting cancer DNA in blood. So how is it revolutionary or different to existing biopsy methods? Well, the vast majority of DNA is circulate in the blood as nuclear proteins called [indiscernible]. And most of this is actually background. However, small amounts of DNA also circulate bound directly to epigenetic regulators called transcription factors. And this DNA, as I say, it's ignored by present methods is our target.
Some transcription factors bind to different DNA locations in the genome or DNA sequences in the cells of cancer patients. However, their isolation from blood has never previously been successful and consequently, the different transcription factor binding that occurs in cancer has never previously been measured in blood samples. We have now succeeded in isolating transcription factors from blood plasma and found hundreds of transcription factor bound DNA sequences in the plasma of cancer patients that are not present in the plasma of healthy people.
As I said, these new sequences represent an entirely new class of cancer biomarkers with hundreds or maybe thousands of new targets available to science for the first time and capture SEQ is an entirely new way to analyze blood samples to find them. So the next step was then to establish a proof of concept for cancer detection by transcription factor occupancy measurement in blood using capture seek. The technical details will be published in the paper when it comes out. But the transcription factor we've worked on is called CTCF. And we've shown in a small number of patients that a panel of plasma CDCF chip seek results identified patients with cancer with 100% sensitivity and specificity. In late terms, we detected all the cancers with no false positives. That was very encouraging, and we have good reason to believe Capture SEQ will be accurate and economic in routine use.
Although we focused on 1 particular transcription factor, TCF, this may be a pathfinder for many other similar tests using other transcription factors that are important in particular cancers. An easy example would be the estrogen receptor as a transcription factor in breast cancer. And perhaps most importantly, this new transcription factor DNA method may be used alone or in combination with other existing methods to bring multi-omic cancer DNA testing to patients for patient management and for early cancer detection. As Cameron mentioned, we are in many confidential discussions, and this is certainly proving a hot topic. So scientifically, a great step forward and hopefully, 1 which will translate into real-world clinical benefits for patients.
We will, of course, update you more fully once the paper is out. I also wanted to take the opportunity to update you on a few other Q3 activities. I was very fortunate this quarter to visit our key collaborators in our lung cancer product development programs. In August, I met with Professor Chen and his team as well as the screening program leaders at the National Taiwan University Hospital in Taipei. During the visit, the IDS in analyzer, which is the automated platform for our test was installed in NTUs laboratory and training was provided by 2 of our team to progress their validation study for lung cancer screening.
We've also performed some analysis regarding use of the new Nu.Q H3K27 trimethyl test in prognostication of diagnosed lung cancer patients in studies similar to our previous collaborative studies in France. I also visited our colleagues in France who are continuing their work using a Nu.Q H3K27 trimethyl in lung cancer, and they're now expanding into other cancers. The clinical lung cancer patient management results in France are consistently excellent, and we're preparing for the introduction of new Nu.Q 3K27-trian metal test in clinical practice in a group of hospitals in France.
There will also be quite a few upcoming publications in cancer in the near future. In August, we also published a paper showing the utility and reliability of our Nu.Q asset and we expect further publications from ourselves and from collaborators over the coming months in net. So a lot of activity. And with that, I'll hand over to Tarek for the finance.
Thanks, Jake, for that thorough and exciting update. Now on to the finance report. Revenue for the third quarter grew 32% over the same quarter last year, coming in at $0.6 million -- at this early stage of commercialization, revenues remain fairly lumpy and difficult to predict from 1 quarter to the next. So we will not be providing revenue guidance at this point in time. Operating expenses for the quarter were down 10% year-on-year and down 18% for the first 3 quarters, primarily reflecting lower personnel costs and lower research and development expenses.
As a result of strong cost management, Net cash used in operating activities was $3.6 million for the quarter, down 33% over the same period prior year. Net loss was down 8% for the quarter and down 20% for the first 3 quarters compared to the prior year. receipts during this third quarter included $1.2 million from a registered direct offering, which included participation by some of our directors. And subsequent to quarter end, we received net proceeds of approximately $6.1 million from a confidentially marketed public offering, including partial exercise of the underwriters' overallotment option. This raise also included inside the participation, demonstrating once more strong managerial commitment.
So to summarize the quarter, revenues were higher by 32% versus prior year. Total operating costs lower by 10%. Cash used in operations was lower by 33%, net loss improved by 8%. And as Cameron reported at the top of the call, we are excited to have signed our first agreement with Werfen and Hologic. One of our key financial goals is to be cash neutral, meaning income, including licensing receipts, matches expenditure on a cash basis. We have made significant progress on cost reductions. However, to fully realize our ambition, we need to execute several significant licensing agreements in the human space and secure existing milestone payments in the vet space. I'm happy to say we continue to make solid progress against each of these targets.
And with that, I will pass back to Cameron for closing remarks.
Cameron?
Thanks, Derek. Before summing up, I'll provide a quick update on QVT. Expanding the global reach of our new Cube bet cancer test remains a key priority. -- enabling veterinarians worldwide to improve canine cancer screening and outcomes. Our supply agreements with leading industry players, including Antech, part of Mars, Science and Diagnostics, Film Vet Systems and IDEXX are instrumental in achieving this. To further accelerate revenue growth and ensure consistent delivery, we have focused on centralized lab automation. At the end of the first quarter, FUJIFILM Vet Systems expanded their contract with us to validate and then implement a centralized automated platform using the IDS i10 analyzer. .
I am delighted to report that the Fuji team have made great progress this quarter in validating and verifying the Nu.Q bet cancer test on the automated platform. We believe the automation of centralized labs is crucial to accelerating our growth rate. So this is a particular area of focus for us. We aim to enable all our large customers to be automated so that they can easily and effectively handle the much larger numbers of tests that would result from having our tests in annual pet wellness panels. Putting our tests into wellness panels would greatly increase sales volumes and will be a key target for 2026.
Notably, this automated platform is the same technology utilized for our human diagnostic products, oh cancer, Nunes and Nucudiscover. -- highlighting the inherent synergy and efficiency of our core new technology. Terrific work from the Fuji team who continue to see steady growth in the use of the Nu.Q test in Japan. On the research and development front, we continue to make progress towards securing the final milestone payment of the $5 million related to our fee line cancer products. In the second quarter, a peer-reviewed paper regarding preanalytics was published, and we plan to present and submit for publication clinical data in the coming months.
In drawing the call to a close, our goal is to secure a wide range of licensing agreements in the human diagnostics space, mirroring our successful strategy in the veteran market and anticipate similar to the veterinary market, diverse deal structures with potential for upfront and milestone payments and future recurring revenue. We believe we have developed a unique and widely political platform -- that will be a big part of both oncology and netosis for decades to come for hundreds of millions of people and animals worldwide.
Cancer and sepsis diagnostics alone represent a combined total addressable market of approximately $25 billion annually, offering substantial revenue opportunities for VolitionRx and our partners. I believe that these next few quarters will be transformative for our company. Our laser focus is on executing license agreements, and we will update you as they complete. Thank you for joining the call today. We very much appreciate it. We will now take your questions. Operator?
[Operator Instructions] Our first question is from Justin Walsh with Jones Trading.
2. Question Answer
Can you provide some additional color on the size of the antiphospholipid syndrome market? And how it compares to other potential new net applications you guys are looking at?
Yes, Justin, thanks. That's a good question. So obviously, the net market is huge. A few -- the big ones are things like sepsis and AKI. And I mean, obviously, they're the biggest or the big -- and for us to start of the program, the first cab off the rank. We're very happy that starting with the tesekind of diseases, which are big worldwide. There are 4 million people who have APS -- so it's considerable. It's not 1 of the biggest markets, but that's a very good 1 to start with. And the TAM where we've calculated is something in the $85 million to $90 million per year. So autoimmune disease is obviously very important for a whole lot of reasons. -- and it's something which is very tough to diagnose.
So we think this is a great first cap off the rank, something, as I said, $85 million or $90 million market or TAM is a very good way to market size to start with. And currently, the way it's diagnosed is far from ideal, and it is very much mix-related. And as you know, the Revitas selling our assays in Europe now, and they're analyzing 21 different uses beyond APS. So there's a large range of ones coming up, but that's the size of the first one. And as we said, we strongly expect to see a range of others.
Our next question is from Yi Chen with H.C. Wainwright.
My first question is, could you tell us whether the Worten partnership has made any contribution to the third quarter revenue -- and also, how do you expect the orphan and how large our partnerships to hit the top line revenue trend in 2026?
Yes. So no Werfen have not accretive to the revenue. They're in the process of validating it on clinical samples for clinical utility. They've absolutely hit the ground running. I think we'll end up with a broader agreement with Work -- they've got it working on their machines. So -- and the machine is -- they're 1 of the biggest in the autoimmune space and coagulation. So I think that will be a big part of what we have going forward. I think our plan has always been and still remains to be that we will be on a range of different platforms.
So these coagulation companies, companies like Werfen Systemix, ago are a very good way to start. They're all large, multibillion-dollar companies. specialists in certain pieces of the netosis market. So I think we're in the first of the rank and the fitter running and I think will broaden the relationship. As far as Hologic, actually an today, they've actually made their first sale. Obviously, it's not in the last quarter's revenue because it's come and gone. But there will be some on this quarter's revenue.
We could not be happy with that relationship as well. They've got a very well compared to us. They're a multibillion-dollar company. At logic, as you know, they're very excited about our epigenetics offerings that presented at quite a few conferences. I've done a lot of social media and marketing. They've trained their workforce. They've also visited our laboratories in Belgium and in California already to really understand it. And as I heard today, they've made their first sale. So I think both are very important to our growth. I think the great thing with both agreements as well as we are in a lot of other discussions as we -- as you know, it does give everyone else a bit of a nudge to when you make deals with their competitors.
So I think it's been transformative in our relationships with our -- the 10 other people we're talking to have been taken so seriously by such large companies that obviously, they're very excited as well. So overall, I'm very, very happy with both the region arrangements with Werfen and with logic. And as I said a few times on this call, we're very active discussions with a bunch of others. I do believe very much going forward. The netosis test, the oncology will be something which is taken by a very large number of people worldwide very regularly. And this is the start of that process that we expect to see a lot more in the coming months and quarters.
Got it. And with respect to those ongoing discussions with additional partnership. How many do you expect to close in 2026?
I guess 1 thing we've never really been on top of is the timing of which ones will happen when it's always tough. These are very important deals for us, but if you are the largest company in the world or the largest companies in the world, they can speed up and slow down. But I strongly expect we'll have a range more. I do expect that we've got some very active discussions going and some of which are in hopefully the latter and final stages. But exactly which ones will happen when it's very hard to say. But I'd be very surprised if there wasn't a bunch more through this year and through next year because I think what gives me that confidence or the closest test is the only way we know measuring this nets are the next big things have been associated with dozens and dozens of different conditions and processes.
On the oncology side, our basic platform in 3.1 and H3K27 is the biggest seller in the vet market. It's making a big splash in the loan market in France and Taiwan and moving to other countries. And as you've heard today, for the first time, again, very, very exciting. Our ovarian, Dr. Malofhas cracked concentration of Chromatin, which is just 1 of the holding ground in oncology. The issue with all the companies in the liquid biopsy space is a very rare target, so being able to concentrate chromatin fragments. And we started with transcription factors, which are the pinnacle of epigenetics. They are the most important factor in all that is just huge.
So I think between all of that, I'm very confident we'll be getting some deals signed with different groups. We have something very special. But as we've said many times, it's bigger than us. There's no way we can commercialize all the different things we're doing. And I think, obviously, the first companies you've seen realized that, and I think it's really starting to pick up with the other companies as well. And the more we sign, the easier they have become to sign because our credibility and track record go up and up and up.
Our next question is from Steven Ralston with Zacks.
First of all, congratulations on the traction you gained on the revenue line in the products and also on the significant reduction of expenses this quarter. And I'd like to dig into both of those. First of all, can you give some sort of breakdown of the product revenues. I know it consists of the nice test and the Discover kits. -- in the vet, was there any like stocking of for Fuji -- or was there some lumpiness in the Discover side?
So this is Terence. Yes, there is still a lot of lumpiness, which is -- makes it a bit difficult to predict and then discover is very project-based. So that's up and down each month and each quarter. What I would say is that, as you can see, both services and product revenue had a very good quarter. And on the pillars side, every pillar made some progress, and we'd expect to continue to make progress through the balance of the year. we don't provide individual growth numbers for the individual pillars. But I do expect that we'll see growth across all the pillars through the full year.
And just 1 thing, Stephen, I think to keep in mind, just to go through them 1 by one. The bet, obviously, we are the biggest selling oncology test in the veterinary market. But obviously, we'd like to be much higher in the millions of tests and tens of millions of dollars in revenue -- that is not going to happen until it's got a centralized lab machine working. But as you heard, that's something we have actually achieved this month, with good validating the [indiscernible], so the platform currently is on microtiter plate work fine. But as you can imagine, that's not an easy thing to do hundreds of thousands of tests on plastic place -- so having the item working, and it's -- obviously, it's made by Revatio large, again, multi-pillar company, is a massive breakthrough for us.
And we're going to focus next year on trying to get the -- getting the big companies to automate. And then there's a real prospect of them putting on this in wellness panels. So if you see them starting to go in a wellness panel for the big companies, that means it's finally taking more of a vertical lift off to the steady sort of slow ramp, which we've been having. So we're very excited about that. To Discover has actually outperformed what we expected. It's been -- we've had, I think, dozens of clients now for different uses, including all the research users and the commercialization, the big companies. And Hologic getting their first customer is very exciting for us because they're out there -- they've got far more rigs than we could ever have, of course, and they're taking it extremely seriously and very energized by this.
And then on the Nu.Q net side, -- the very big companies and the big milestone payments take time. But in the meantime, the problem we have in Europe of all those different hospitals, 14 hospital networks using the system in 5 countries for I think it's 23 different net related uses now. Now they're all just buying them now initially to work out a cutoff for what each use is but we'd expect them to start with clinical utility in the next year as well. And so they should really start to take off as well and distributed by remit. So that makes it much easier. And we do expect the first clinical use of the oncology platform in Europe, in France, as we talked about, in Leonsometime in the next quarter or 2 as well.
So everything is getting there. It's been -- it's 1 of those things. We've got a lot of things going on, and they always take some less the airplane taking us some time to take some time to get off the ground and then we're really hoping at least some of those happened in the next few months and quarters. and we can really turbocharge the revenue in the best space in the Discovery space, in the net space and the model space. And we're doing everything we can to put those things in place. so that it comes from something where we're getting good sort of organic growth to a real lift off, which is what we all want.
Does that make sense ?
I'd actually like to pursue the revenue line a little more because as an analyst, I have to do financial modeling, and I'm looking at it by product line and the addressable markets that they have. And I realize it's a very naciant stage in terms of revenue right now. And -- but thinking about it long term, I mean, right now, well, actually over 80% of the revenues in this quarter were in the product line. and looking at accounting rules, and that sort of thing, segments usually break down by when they achieve over 10%. Do you think there'll be a time where you'll actually break it down that you'll see -- we'll see product lines like in the vet space and discovering each 1 of your pillars having a separate revenue line or segment revenue going?
Yes. I think as pillars mature and each revenue line becomes more meaningful, I think it would make sense to then provide that level of detail at the moment. each pillar in and of itself is still relatively small and like I said, quite lumpy. And so for the foreseeable future, I think this is how we'll report it. But as soon as I think we get some significant growth. So for example, as Cameron mentioned in the vet space, that start to get adopted into the wellness plans and takes off, I think it would be to split that out and report that pillar separately. -- or likewise, any of the others when they cross certain milestones. But in the meantime, we're happy to give you bit of color on these calls, but we're not splitting that further at this time.
And to be clear, I'm just to reiterate, on the revenue side, that obviously the product revenue is important in the short term, but we see more of kind of priming the pump proof-of-concept proof of product to license. If this is going to be taken up worldwide and Internet is the biggest thing out there, which I think it could well become by 2030 or 2032. This could easily be in the hundreds of millions of tests per year at the TAM that's clearly not going to be upsell selling that product, and we don't want that sales force. We don't want the process. .
So we're out now through our partners and licensees to sort of show that it works. But the bigger it gets, the less we'll end up doing that we'll make the money from the key components and the royalties and licensing revenues rather than the process I think if you're looking into how it fits together in the short term, it will be more product-based because we're showing it works in these kind of relatively smaller sales. But once it really takes off, and I think I'm very, very excited with the potential in the oncology space and also in the ptosis space. That's when it will -- the licensing revenue will draw the product revenue because these big companies have a reach that we're never going to want to have -- so does that make sense, Stephen? And so it will change from a lot of product revenue to overwhelming licensing revenue that goes the way we expect.
Moving on to the expenses. -- the actually year-over-year and the sequential improvement was dramatic, much more than I expected. And somehow I had some sort of an indication that like the second quarter relative expenses were like going to be the floor now, but you made such a huge jump here in the third quarter. And actually, it's kind of high proposed it's about like the 1-year anniversary since you announced the cost-cutting program. Do you think you've come to the end of the cost cutting and this is more of the baseline? Or is there still more to come?
So I would certainly say it gets more difficult to beat the prior year because we started making progress in the third and fourth quarter of last year on the cost savings program. And so you're battling against a tough comparative -- but yes, I said the hope that we can continue to make progress, but it may not be as steep as we made year-to-date.
And Stephen, it's a lot being to our investors as well, obviously, we've been having to raise money and it's a tough market. So we really want to spend -- and we have -- I think we've developed some of the most remarkable technologies with that money, but we're also aware that the market is tolerable at the moment. So we need to save every single penny. So tariff has been extremely good at. But it's a balancing act. You're not going to become a successful company just by cutting. You've got to deliver the deals and the products, which we're in the process of doing.
So we've drastically cut our workforce and our expenditures. But at the same time, we managed to launch a range of products. And that's the balance we take every day. because I mean, the cutting has been crucial. We had to listen to the market and had to listen to what's going on at tough. But we also have to deliver. So something we heard that needle every day. But -- yes, so we'll see how that goes on the deal with being signed. But the big difference now, I think the value of the company now isn't necessarily from cost cutting, it's from delivering deals and licensing arrangements and sales.
So -- but in no situation, are we going to allow the expenses to blow out. We've got to keep it tight. It's very hard to raise capital at the moment as we all know. So we have to do as much as we can a little, but we do have to deliver at the same time. So it's a balance.
And last question, and hopefully, this is a short one. I noticed that in a recent conference, it was mentioned that some preliminary results from the ongoing lung cancer study were presented. Was there any new information there?
No. That's -- there's actually a lot going to be presented at the conference in Chicago in December. The North American...
No, this is the 1 Chicago, .
Yes. No, they're getting there. So there's a lot of new data being compared in meal, and we expect it to be in routine use. This will be the first time our testament routine use in humans that's coming up in the short term. and tapes done a lot of work as well. So I expect to see later this year and early next year, but there's nothing -- I believe nothing new, nothing new in that process. But they are -- that's not a lack of activity. They are in the process of doing a huge amount -- and so that's our basic 2 platform. And then we hope to be able to add on arrangements in the more complicated -- slightly more complicated areas of capture and process, but both progressing well. .
Our next question is from Bruce Jackson with the Benchmark Company.
We could so if we could start with the -- I know the terms of the agreements with Werfen and Hologic were confidential, but -- just broad brush, Were there any upfront payments in those agreements?
Yes, they were in [indiscernible]. Not as I said, we start smaller and then we expect them to get bigger and bigger with every deal. But yes, there were upfront payments and ongoing payments from working -- so to the earlier question, there were some not product income from them, but working did have some I can't discuss that too much more. They're confidential, but yes, they were and there are ongoing. And Hologic, it's a co-marketing so it's not upfront, but they are very active and I have made defer sales that will contribute to our revenue in the short term.
Okay. And then second question, the milestone for the feline cancer testing, where do you think that might hit ?
So it's in the process. So we're just in the final stages of getting the last cap, which has actually taken longer than we thought. -- finding cats with cancer isn't an easy process, but we're getting there. So upon that, under the terrace agreement, it will be due on a -- I'm not sure it's public which we can say the times to come, but the times go in the agreement with Antech -- but as soon as the paper is published, that is a process where we can -- do you want to go through that, what can we say exactly what is on...
Well, what I would say is that the conditions to meet the milestones that we need to get a paper published. And then the payment follows thereafter depending on, again, either the launch the first commercial sale of a test or there's also a time line by which they have to pay to us. So what we're -- we hope that once we've completed the study, got the paper published that shortly after that, we would be looking for that milestone payments be paid -- so the only reason...
It's up to the finishing the paper. And as you know, on it takes some time sometimes, but I'm very operose to getting that across the line, and then yes, then we're in a position to ask for that payment.
So publishing the paper triggers the milestone. Is that correct? .
That's correct.
Okay. Got it. Then last question, there were some Series A warrants that were out there. that were milestone-based. Has that milestone been met with the announcement of the agreements? Or is -- what are the conditions for that?
The conditions were an aggregate of milestone payments, which is higher than the milestone payments that we have, so it has not been triggered yet. .
Are no further questions. I would like to turn the conference back over to Cameron for closing remarks.
So thank you, everyone, for coming on the call today. I really appreciate your time. There's obviously a lot going on at volition in all of our pillars, obviously, it's a very tough market at the moment for other shareholders, and we do understand that. So we're doing everything we can to deliver what's going to make us a very successful company. If we achieve them all, things we are making very strong progress. As I said in the vet market, we've got the i10 validated now for centralized labs. -- which we're hoping will lead to other companies doing centralized labs and wellness tests, which would be transformative for our revenue in the vet space the new few net, we're making a lot of progress in Europe with our fantastic partners at Revet, who are selling them to 14 hospital networks now.
They're working on the cutoffs in the range of a couple of dozen different uses for net -- we signed our first 2 human deals in the net space, starting with APS, which, as we said, has like a $90 million-ish million TAM, so it's a good start. But we do expect a lot more. Jake, as announced, he has submitted a publication on the capture side, which is very exciting. We're making strong progress on the lung cancer side in both France and in Taiwan, and we expect it to be used in the first clinical sets in the short to medium term as well.
So a huge amount going on, and I'd like to thank you all for having interest in the company. and keeping track of what we have. We expect to see a lot of news on all those fronts in the coming months as well as we continue to deliver on the commercialization plan. So thank you very much for your time today.
Thank you. This will conclude today's conference. You may disconnect at this time, and thank you for your participation.
VolitionRX — Special Call - VolitionRx Limited
1. Question Answer
Great. Good morning, everyone. I'm Alexandra Byrne. I'm a reporter at GenomeWeb, and I will be your moderator for today's webinar. The title of today's webinar is beyond the genome: Measuring Epigenetic Modifications Across Matrices for Biomarker and Drug Discovery and it is sponsored by Volition. Our speakers today are Eric Ariazi, Chief Development Officer of Helio Genomics; and Marielle Herzog, Research and Development Director at Volition.
You may type in a question at any time during the webinar, you can do this through the Q&A panel, which appears on the right side of the webinar presentation. If you look to the bottom tray of your window, there is a series of widgets to enhance your webinar experience. And with that, I'll turn it over to Marielle.
Thank you very much. Hello, everyone. Good morning, good afternoon, good evening, wherever you might be. I'm delighted to be here with you today for this women focusing on Nu.Q Discover and how Nu.Q technology could help to accelerate epidrug development.
About volition. So Volition is a multinational company. We have colleagues all around the world with 2 lab, 1 R&D lab and service in Belgium and 1 laboratory in the U.S. in San Diego. Our mission is really to stabilize and improve outcome of millions of people worldwide. But before diving into the core of this presentation, let's take a moment to have a look on the background behind the Nu.Q technology.
So nucleosome, the fundamental structural unit of chromatin, they play a crucial role in compacting DNA into chromosome and allowing the genome to fit into the cell nucleus.
Nucleosome in case of cell death are high cell turnover. Chromatin is fragmenting. And the nucleosome can be released into the environment or the blood -- like the blood flow. Nucleosomes are composed of approximately 140 base pairs of DNA wraparound in histone core proteins, histone and especially the histone cell are subject to Histone post-translational modification, also referred to as epigenetic modification such as methylation, acetylation, phosphorylation, ubiquitination and many others.
Those modification can be added by enzyme also known as writer, could be removed by eraser or could serve as a docking site for other proteins. Writer, eraser and reader could be target for epidrugs.
Those modifications are a key regulator of several processes like regulation of gene expression, DNA damage or cell differentiation. Alteration of nucleosome or histone PTM levels can lead to disease like cancer, but also inflammatory disease, autoimmune or neurodegenerative disease.
Nu.Q assay consists of sandwich immunoassay with a capture antibody targeting specific epigenetic feature present on the nucleosome. And with an anti-nucleosome antibody in detection. Those assay are quantitative, results are expressed in nanogram per mL. And they allow to determine the level of circulating in nucleosome but also to profile the nucleosome.
The assay analytically validated in K2 EDTA plasma, but we will see in a couple of slides that then can be used in other type of matrices. Only few microliters are required to perform the assay.
Today, the Nu.Q Discover portfolio consists of 14 different assays, each assay targeting a specific epigenetic modification like methylation, acetylation or other PTM. We have also a test targeting a mutation. Those tests are highly specific with no or very limited cross-reactivity, are highly reproducible. It can detect up to few nanogram per mL of nucleosomes in the blood.
This portfolio can be and will be expanded, and our experts are available to support you for any of your histone PTM needs. All those assays are available on an automated chemiluminescence immunoassay platform using magnetic beads. 2 of them are also available as a manual ELISA assay and a point-of-care test is currently in our development pipeline.
As I mentioned previously, all those Nu.Q assay can be used with multiple different type of matrices from cell culture using supernatant or cell chromatin extract to tissue and blood with not only plasma but also some blood cells in animal model or in human, allowing to cover all the different steps of the drug development from discovery, preclinical to clinical.
Just 3 examples, the first one on the cell line, where cell lines were treated either with an HDAC inhibitor here on the left or with an EZH2 inhibitor. Cells treated appears in the red and untreated in gray. Results are expressed as a ratio of the PTM over the Nu.Q H2.1. As you can see for the HDAC inhibitor treatment, we observed a clear decrease of the level of -- or clear increase, sorry, of level of acetylated mark in the treated cells without affecting the methylation mark, K9 or K27 methylation.
Whereas for EZH2 inhibitor, which target H3K27 methylated mark, we observed a decrease of this mark in the treated cells, but specifically of the H3K27me3, but no effect on H3K9me3 or any other acetylated marker.
A second example, after chromatin extraction, Nu.Q assay were able to profile the epigenetic modification present on different type of tissue, for example, here, lung, pancreas, prostate and also to compare normal tissue versus a tumor.
Results are represented here as a heat map, where the red shows the highest level of histone PTM or specific histone PTM represented as a ratio and the blue at the lowest level.
Then a third example where Nu.Q assay can track epigenetic modification on blood cell, for example, PBMC monocyte. And you can see that you can really have the different profile according to the different cells.
So I gave you a global overview of this technology. Now I will hand over to Eric, who will show you some studies and results, illustrating how the Nu.Q Discover technology can be used, especially in plasma to really investigate key parameters like tumor burden, dose optimization for drug discovery, pharmacodynamic toxicity, but also to evaluate predictive biomarker or discover new biomarker. Eric?
Thanks, Marielle. That was a nice introduction of the Volition technology, and now I can take it from here. I'm a translational cancer biologist and biotechnology executive with over 25 years of experience spanning academia and industry, advancing precision oncology and epigenetic assays from discovery through clinical development. Currently, I am the Chief Development Officer at Helio Genomics. I lead cross-functional teams to develop blood-based multi-omic cancer diagnostic assays.
Some quick disclosures. I'm a former employee of ORIC Pharmaceuticals, and I have stock in ORIC Pharmaceuticals. I will be showing some data about ORIC's EED inhibitor, ORIC-944, and the case study data were originally presented from posters presented at prior AACR meetings. I'm also a former independent consultant for Volition.
But first, I'd like to talk to you about an overview of histone modification. As Marielle mentioned, histones can be modified by writers and erasers. Writers deposit either acetylation or methylation marks. Acetylation marks open up the chromatin so it's more accessible to transcription factors and are associated with increased transcription. Methylation marks can either increase chromatin accessibility or decrease it to regulate transcription.
For example, while H3K4 dimethylation and trimethylation marks usually occur at active genes, H3K9 trimethyl and H3K27 trimethyl marks are typically associated with gene repression.
The Nu.Q assays for monitoring a variety of epigenetic marks are shown on the sides of the slide. At the bottom of the slide is a schematic showing the main methylation sites on histones H3 and H4. The methyl transferases are shown on top of the histone map and the demethylases at the bottom.
As a case study, we will focus on the PRC2 complex with its EZH2 catalytic subunit that Trimethylated H3K27. Let's start by talking about detecting cancer using these Nu.Q assays for circulating cell-free nucleosomes. Volition collaborators took a panel of Nu.Q cell-free nucleosome assays for trimethylation of H3K27, H3K36, H3K9 and dimethylation of H3K4.
They looked at the levels of these marks in non-small cell lung cancer sample versus healthy controls. They found that trimethylated H3K27 showed the highest increase of the markers in the panels with increases of approximately 3.7 or 2.9-fold in training and validation data sets when comparing the medians between non-small cell lung cancer group and the healthy group.
Further, H3K27 trimethyl levels showed the best area under the Receiver Operator Characteristic Curve or ROC curve with values of approximately 0.9 in the data set and with a sensitivity of about 70% at 90% specificity. Based on these results with H3K27 trimethylation showing diagnostic potential, the volition collaborators performed an IHC staining study in non-small cell lung cancer tissues compared to healthy tissues.
And what they saw was variable H3K27 trimethyl staining, but with increased staining associated with grade. Specifically, there was a lack of strong H3K27 trimethyl staining at Grade 1 but increased staining -- strong staining at Grade 2 and at grade 3. Further, Grade 3 cancers no longer showed weak staining compared to Grade 1 and 2 cancers.
Thus, there was a significant association between H3K27 trimethyl staining and increasing grade. To investigate whether circulating H3K27 trimethyl nucleosomes could provide additional information for monitoring the presence of non-small cell lung cancer during treatment in combination with circulating tumor DNA, that is cell-free DNA fragments with cancer gene somatic alterations, H3K27 trimethyl nucleosome levels were measured in healthy subjects and then compared to that in the non-small cell lung cancer patients along with ctDNA status.
In a healthy cohort, the upper limit of H3K27 trimethyl nucleosomes was established at 22.5 nanograms per mL based on one standard deviation above the 95 percentile. Using this cutoff, 38.8% of non-small cell lung cancer patients were categorized as H3K27 trimethyl positive.
A next-generation sequencing analysis using a panel containing 78 cancer genes covering the majority of drivers of non-small cell lung cancer was used to detect ctDNA. The presence of at least one somatic alteration or copy number variation was considered a ctDNA positive sample. In this non-small cell lung cancer cohort, 43.1% of patients were categorized as ctDNA positive.
When considering the additive value of combining H3K27 trimethyl status to ctDNA status, an extra 15.1% of patients could be identified as having circulating tumor material detected. This is significant because now the number of patients can be increased that can be tracked with the blood-based assay. Moreover, as demonstrated in our ROC curve analysis, using H3K27 trimethyl positive status alone achieved an AUC of 0.79, but adding ctDNA positive status improved the AUC to 0.87, demonstrating that combining the 2 analytes further improves tracking tumor burden as defined by liquid biopsy assays.
So why would we find H3K27 trimethyl levels to be diagnostic in non-small cell lung cancer? Well, EZH2 is the histone methyltransferase that catalyzes trimethylation of H3K27. And its high expression is prognostic in non-small cell lung cancer and various other cancer types. Here is a meta-analysis of non-small cell lung cancer, including 10 different studies with almost 1,700 patients. And what we found was a combined hazard ratio of about 1.7, indicating that EZH2 is indeed prognostic for overall survival.
Likewise, in myeloid neoplasms, we have another meta-analysis in 8 different studies. And again, a very significant overall hazard ratio. This time, it was 2.4. Furthermore, EZH2 is a prognostic indicator in multiple other cancers as shown here, including breast, glioblastoma, gastric and gynecologic cancers.
Next, how can these Nu.Q assays be used in epigenetic drug development? Well, this is where my case study with ORIC-944 comes into play. For this case study, I would like to tell you a little bit about PRC2. PRC2 is a multi-subunit complex known to play a role in regulating stem cell identity and cell differentiation through transcriptional silencing of target genes.
EZH2 resides in the PRC2 complex. The PRC2 complex also contains SAS12 and EED subunits. SAS12 is a scaffolding subunit, while EED is the reader subunit that allosterically regulates the EZH2 subunit. So while EZH2 writes or catalyzes trimethylation of H3K27, it's the EED subunit that regulates whether EZH2 is active or not.
Elevated PRC2 activity and trimethylation of H3K27 is associated with poor prognosis in patients with metastatic lesions. And first-generation EZH2 inhibitors such as tazemetostat have been approved in epithelioid sarcoma and follicular lymphoma. Since EED regulates EZH2, EED inhibitors offer another chance to target PRC2. At ORIC, we were interested in developing the EED inhibitor, ORIC-944. This EED inhibitor is orally available with picomolar activity in biochemical assays and nanomolar activity in cellular assays.
At first, it was verified using the diffuse large B-cell lymphoma model, KARPAS-422, grown as xenografts in immunocompromised mice. This model has been widely used to demonstrate efficacy of tazemetostat. In this model, we looked at tazemetostat and compared it with ORIC-944. We observed that ORIC-944 at 100 and 200 milligrams per kilogram dosed once daily was more efficacious than 200 milligrams per kilogram tazemetostat that was dosed twice daily.
Next, we were interested in metastatic castration-resistant prostate cancer. Since EZH2 has been implicated in this advanced form of prostate cancer and tested ORIC-944 in enzalutamide resistant 22RV prostate cancers. Here, we saw a strong single-agent activity ranging from 25 to 200 milligrams per kilogram of ORIC-944 dosed once daily. For comparison, 22RV1 tumors were resistant to the androgen receptor antagonist enzalutamide, consistent with prior reports.
Now if we look at H3K27 trimethylation levels by IHC staining in the tumors itself, we can see that at baseline, there were very high levels of H3K27 trimethyl -- but with increasing doses of ORIC-944, there were increasing reductions in trimethylated H3K27 levels, demonstrating target engagement. Based on these results, ORIC-944 has gone into a Phase I clinical trial sponsored by ORIC.
To implement this clinical trial, we needed to have a biomarker plan. So we developed 3 different biomarker assays in preclinical models. The first one is a skin punch biopsy. Mouse skin was stained for H3K27 trimethyl by IHC. The H3K27 trimethyl staining was evident in the epidermal layer of the skin and in the sebaceous gland. But in mice treated with ORIC-944 for 7 days, the staining disappeared.
The staining was quantitated, and indeed, we saw a dose-dependent reduction in H3K27 trimethyl labeled cells. The advantages of this assay are, there was no tumor biopsy, and we did see a dose-dependent response. But the assay is only semi-quantitative and the dynamic ranges are limiting as the range of the values is large.
Additionally, scoring all these positive cells takes a long time. Yet the skin punch biopsy assay has been employed in the clinic as demonstrated by this Phase I dose escalation study with tazemetostat. Skin punch biopsies were collected from 32 patients at baseline and on treatment. H3K27 trimethyl IHC staining was performed, and it was observed in the stratum spinosum layer of skin. Significant reductions were observed and taking this data and putting it into a maximum inhibitory effect model show that target inhibition of the H3K27 trimethylation mark was near maximum or near about 80% in the 800-milligram twice daily cohort.
What this model says is if you were to double the dosage to 1,600 milligrams twice daily, you wouldn't have much more increase in the reduction of H3K27 trimethyl. Therefore, the skin punch biopsy assay is a viable assay to assess EZH2 inhibitor target engagement in the clinic and can be used to inform the dosage required for maximum target reductions. But the skin punch biopsy assay can be challenging if you want multiple time points, and this is not comfortable for the patient.
Next, we went on to an AlphaLISA assay to measure H3K27 in mouse monocytes. The cell input for this assay was optimized to avoid a hook effect where excess analyte overwhelms the finite amounts of antibodies and beads in the assay. With this assay, we saw a very large reduction almost down to baseline.
Likewise, when the EZH2, EZH1 dual inhibitor, CPI-0209, now known as tulmimetostat was being evaluated in a first-in-human trial, a similar monocyte assay was employed. Again, a dramatic reduction in H3K27 trimethyl levels were observed in human monocytes. However, if you look at the dosages, you can see that even the lowest dose achieved a near maximal reduction and not much more reduction was seen with increasing dose.
In summary, with this monocyte assay, the advantages are, again, there's no tumor biopsy and you can perform longitudinal sampling, but it requires monocyte isolation from whole blood. Hence, you first need to collect whole blood from the patient and then send it to a central laboratory for monocyte isolation. But monocyte preps after shipping whole blood overnight, even on ice are poor because those monocytes start dying during shipping. Then you need to optimize the cell input into the assay to avoid a hook effect. So this assay requires quite a bit of technical optimization, and then there's this lack of the dose response.
After working on the monocyte assay, we wanted to look at circulating H3K27 trimethylation at the cell-free nucleosome level in plasma. And for this, we used the Volition Nu.Q assay. We used immunocompromised mice implanted with 22Rv1 prostate cancer cells and then treated them over the course of a week, sacrificed the animals, collected the blood, processed it to plasma and measured H3K27 trimethylation.
After treating the mice for 7 days with 10 to 100 milligrams per kilogram ORIC-944 once daily, we saw a dose-dependent reduction in circulating levels of normalized H3K27 trimethylation. We also looked at the frequency of dosing. Over a 7-day period, we dosed for 3 days, 5 days or 7 days, and we saw a frequency-dependent decrease in normalized H3K27 trimethylation levels.
Then we wanted to check, is H3K27 trimethyl coming from the tumor or is it coming from the host cells? In essence, is it tumor selective? For this experiment, we had both tumor-bearing and non-tumor-bearing mice. They were treated again for 1 week. If we look at the nontumor-bearing mice on the right side of the plot, the H3K27 trimethylation levels are already fairly low in the vehicle-treated group, and we did not see a further significant reduction in normalized H3K27 trimethylation.
But when it comes to the tumor-bearing mice, the baseline levels of H3K27 trimethyl were elevated, and now we could see that reduction with ORIC-944. Therefore, because H3K27 levels are low in nontumor-bearing mice but high in mice with tumors, we concluded that H3K27 trimethyl is indeed selectively coming from the tumor.
Furthermore, we concluded this blood-based assay is capable of reading out histone post-translational modification target engagement in the tumor itself. The same exact circulating H3K27 trimethylation assay normalized to total H3.1 was used by another group of Volition collaborators that were working on the CARE clinical trial.
The CARE trial is a Phase II study testing tazemetostat in combination with an anti-PD-L1 antibody. As shown on the right -- as shown in the left panel, an evaluation of 191 patients samples across multiple time points in aggregate shows that at cycle 1, day 1, the H3 H3K27 trimethyl over H3.1 ratio was high at 0.56. But at day 1 of cycle 2 and cycle 3, the H3K27 trimethyl over H3.1 ratio was significantly reduced to 0.31 and was still reduced at the end of treatment.
As shown on the right panel, if we take a subset of patients where all time points were evaluable, we can examine the data longitudinally. This longitudinal analysis confirmed the decrease in normalized H3K27 trimethylation levels was already occurring at cycle 2 and was maintained throughout the end of treatment. Therefore, this assay can be used in the clinic to follow pharmacodynamic activity of EZH2 inhibitors.
In conclusion, for this section, I'd like to restate that H3K27 trimethylation as a pharmacodynamic biomarker can be measured using Nu.Q assays that are both quantitative and robust. We've shown dose dependency, frequency-dependent responses and tumor selectivity. It's noninvasive. It's already optimized and the turnaround time is rapid, often within a week.
I'd like to point out that in the CARE trial, the trial's aim is to evaluate a combination of tazemetostat with an anti-PD-L1 antibody. Combining EZH2 inhibitors with Immune Checkpoint Blockade or ICB therapy is a growing area of interest in the clinic because there are multiple mechanisms by which EZ2 inhibitors can augment or potentiate ICB therapy.
This slide illustrates how EZH2 inhibitors can enhance cancer immunotherapy, particularly when combined with immune checkpoint blockade. Starting on the left, we see the cancer immunity cycle, the multistep process by which the immune system detects and eliminates tumor cells. This cycle involves the expression of tumor antigens, activation of T cells and infiltration of effector immune cells into the tumor microenvironment. EZH2 normally suppresses several steps in the cycle such as antigen presentation, cytokine signaling and T cell infiltration, helping tumors evade immune detection.
The right panel addresses how inhibiting EZH2 lifts this suppression. When EZH2 is inhibited, there is an increased expression of endogenous retroviruses, activation of interferon pathways and restoration of tumor antigen visibility. This boosts the recruitment and function of CD8-positive T cells, NK cells and invariant natural killer T cells. Thus, these effects of EZH2 inhibition helps convert cold tumors, those lacking immune infiltration into hot ones that are more likely to respond to immunotherapy.
By targeting EZH2, we can also disrupt immune evasion tactics by blocking regulatory T cell-mediated suppression and blocking infiltration of myeloid-derived suppressor cells. Thus, EZH2 inhibition represents a compelling approach to overcome ICB resistance and extend the reach of immunotherapy to more patients.
Here, I'd like to dive in a bit more into how EZH2 inhibition can increase expression of endogenous retroviruses or transposable elements to trigger a viral mimicry response that promotes antitumor immunity. In Panel A, we see the general mechanism. Transposable elements normally silenced by DNA methylation become reactivated when methylation is reduced during cancer progression or treatment.
This DNA hypomethylation leads to reactivation of transposable elements, which produce double-stranded RNA. This mimics a viral infection, activating sensors like IFI-H1, RIG-1 and toll-like receptor 3, which in turn induce interferon beta and T cell activation. Panel B provides an example in triple-negative breast cancer where treatment with paclitaxel alters S-adenosylmethionine's metabolism and causes DNA hypomethylation, but tumors can still escape immune detection.
When EZH2 targets the transposable element promoters by tri-methylating H3K27 to maintain their silencing despite DNA hypomethylation. However, if we inhibit EZH2, this histo-mediated repression is lifted, allowing for the transposable element re-expression and double-stranded RNA accumulation, which in turn activates the viral mimicry pathway. This enhances innate immune signaling and can make tumors more visible to the immune system, especially when combining with immunotherapy.
Based on the aforementioned effects of EZH2 inhibitors helping to overcome resistance to ICB therapy, there's a growing body of clinical trial activity designed to test this in patients. The CARE trial -- as shown previously and on the third trial shown here is one such example. As this slide shows, at least 6 clinical trials as of 2024 are currently investigating combining an EZH2 inhibitor with an anti-PD-1, PD-L1 or CTLA-4 antibody in solid tumors or in refractory diffuse large B-cell lymphoma.
These trials span Phase I and II, indicating early but expanding interest in this therapeutic avenue. This represents a strategic shift, moving from monotherapy to rational immunoepigenetic combinations to overcome resistance and broaden the reach of immunotherapy.
Now I'd like to switch gears and talk about how can the patient population be expanded to offer PRC2 inhibitors to the most individuals possible. In lymphomas, the H3K27 trimethylation is elevated because there's frequently a mutation in EZH2 or there's co-expression of both EZH1 and EZH2 at very high levels, they can lead to accumulation of H3K27 trimethylation. But there are also other epigenetic factors that oppose PRC2, such as the SWI/SNF complex, also known as BAF and PBAF complexes in mammals, which remodel nucleosomes in an ATP-dependent fashion to regulate chromatin accessibility and allowing Histone acetyltransferases or HATs to acetylate histones. So if there are inactivating mutations in SWI/SNF subunits such as ARID1 or SMARCA4 or in other factors like BAP1 and MLL2, then they no longer oppose PRC2 and H3K27 trimethylation accumulates. BAF and PBAF subunit members are mutated frequently in human cancers and in total are mutated in approximately 20% of all cancers.
Specifically, SMARCB1 is mutated in 99% of rhabdoid tumors, a deadly pediatric cancer of the CNS as well as frequently mutated in kidney and soft tissues, while ARID1A is also mutated in about 40% of endometrial cancers and 26% of bladder cancers. With this epigenetic antagonism between SWI/SNF and PRC2 in mind, there is a Phase II clinical trial testing the EZH1, EZH2 dual inhibitor, tulmimetostat, where patients were recruited into 6 tumor cohorts.
Of these 4 solid tumor cohorts were based on ARID1A mutation or BAP1 loss. Two other cohorts were lymphoma and prostate cancer because there has been activity in those indications before. Among the solid tumors, the ovarian, endometrial and mesothelioma cohorts with ARID1A and BAP1 alterations showed good efficacy as seen here in the waterfall plot.
These cohorts achieved eligibility for Stage 2 expansion. Complete and partial responses were also observed in the lymphoma cohort. These findings support including patients with tumors containing ARID1A alterations or BAP1 loss and continuing investigations of EZH inhibitors. These clinical results bring up the question, can H3K27 trimethylation be used as a biomarker in SWI/SNF family drug development?
This figure shows the BAF complex, which as previously mentioned, is a mammalian version of the SWI/SNF complex discovered in yeast. Considering the BAF complex, there exists a synthetic lethal relationship being exploited by pharma companies between the catalytic ATPase paralogs, BRM or SMARCA2 and BRG1 or SMARCA4 and also between the DNA targeting paralogs, ARID1A and ARID1B.
In the case of synthetic lethality between BRG1 and BRM, BRG1 is mutated in 10% of non-small cell lung cancer. So if there is a non-small cell lung cancer with an inactivating mutation in BRG1, you can treat with an inhibitor against BRM and completely block BAF complex activity in the tumor but not infect normal cells in the body, which contain wild-type BRG1.
Similarly, ARID1A is frequently mutated in up to 40% of uterine cancers. So if you treat ARID1A mutated uterine cancer with an ARID1B degrader or inhibitor, then you should again block the activity of the BAP complex in the tumor, but not in normal cells.
Now this is important relative to H3K27 trimethylation because, as mentioned, if you completely inactivate the BAP complex in tumors, this should lead to accumulation of H3K27 trimethylation which can be measured in circulation with the Nu.Q assay. Additionally, since SWI/SNF-mediated nucleosome remodeling also allows for improvement of half the genomic regions, blocking SWI/SNF activity may also be monitored by measuring reductions in circulating acetylated marked H3K27 nucleosomes.
In summary, we discussed a wide range of topics. We discussed how Nu.Q circulating nucleosomes can be used to detect non-small cell lung cancer. We examined how H3K27 trimethyl normalized to H3.1 can be used for pharmacodynamic monitoring of PRC2 inhibitors. We reviewed how EZH2 inhibitors could overcome ICB resistance, and we looked at how patient selection and pharma activity is expanding to SWI/SNF family member mutations, and this is another opportunity for H3K27 trimethyl levels to be used as a biomarker.
We've taken a lot of your time. And with that, I'd like to switch over to questions.
[Operator Instructions]
We would like to ask attendees to take a moment after the webinar has ended to take our exit survey to give us your feedback.
The first question will be for Marielle, which is just where and how do I access the assays?
Thank you. So you can contact directly Volition, but we are also happy to share that you can find our assays through [indiscernible] And you can scan this QR code to learn more how to get access through them.
Great. And on to the next question, which will be for Eric. You showed some data demonstrating that post translationally modified cell-free nucleosomes could aid in the detection and monitoring of non-small cell lung cancer. Do they also serve as prognostic markers?
Thank you. So I have a prepared answer for this. In the webinar, I presented several meta-analyses demonstrating that EZH2 is prognostic in non-small cell lung cancer, myeloid neoplasms and other malignancies. Given this, it is biologically possible that elevated levels of H3K27 trimethyl as a downstream product of EZH2 activity and measured on CF nucleosomes could also serve as a prognostic biomarker.
This hypothesis is supported by a study presented at the 2025 European Lung Cancer Conference as a follow-up to the 2023 non-small cell lung cancer study shown in this webinar.
An interim analysis of the follow-up study examined over 600 non-small cell lung cancer patients and demonstrated higher baseline levels of H3K27 CF nucleosomes were indeed associated with significantly worse outcomes.
Specifically, patients with high H3K27 trimethyl nucleosome levels had a mean survival of 13.4 months, compared to more than double the survival time of 27.4 months in patients with lower levels of this marker. The hazard ratio was 3.56, indicating a strong and statistically significant prognostic impact.
It's worth noting that this analysis used a higher cutoff of 53.7 nanograms per mL of H3K27 trimethyl CF nucleosomes as opposed to the 22.5 nanogram per mL threshold reported in the earlier 2023 study. This suggests that the threshold optimization may be important when applying this biomarker for prognostic purposes. Overall, these findings support the potential of H3K27 trimethyl cell-free nucleosomes as a noninvasive, epigenetically informed prognostic biomarker in non-small cell lung cancer. Thank you.
Yes. And then another question. Can you just talk about the ways in which the Nu.Q assays facilitate early toxicity detection during drug development?
Sure. The H3.1 assay as a readout of total cell-free nucleosomes in circulation can serve as an indicator of toxicity as it provides a sensitive method for detecting systemic cell death in a patient. For instance, Volition has developed the H3.1 Nu.Q assay to detect sepsis, a condition characterized by acute cell death. But the same principle applies to detecting lower levels of cell death induced by therapeutic agents.
Importantly, the detection of H3.1 CF nucleosomes as a readout of cell death does not require the compound to be epigenetically active. Therefore, if a therapeutic agent induces toxicity in any tissue, cancerous or noncancerous, it should result in increased H3.1 levels in circulation.
In preclinical oncology studies, animal weight is commonly used as a surrogate indicator for toxicity. However, weight loss can also reflect other nonspecific effects such as reduced food intake, altered metabolism or CNS effects. Incorporating the H3.1 Nu.Q assay alongside weight measurements can help discern true cytotoxic effects from nonspecific effects.
Moreover, formal preclinical toxicity assessments can leverage this assay by measuring H3.1 CF nucleosome levels in nontumor-bearing animals treated with investigational compound and comparing them to vehicle-treated controls. Tissue-specific toxicity, such as hepatotoxicity could also be evaluated using liver explant models with H3.1 levels measured in conditioned media as a proxy for cell death. Overall, the H3.1 Nu.Q assay offers a robust and highly sensitive tool for early toxicity detection across multiple contacts and drug development. Thank you.
Yes. And then one more for you, Eric. How do the Nu.Q assays support the discovery and validation of predictive biomarkers that can identify responders and nonresponders in clinical trials?
For therapeuters that target the epigenome, that is epidrugs, it is reasonable to hypothesize that clinical responders may be enriched in the subset of patients with elevated levels of specific histone post-translational modifications targeted by the epidrug. Nu.Q assays detect specific histone PTMs, making them well suited for patient preselection and predictive biomarker development.
For instance, in the non-small cell lung cancer study presented in this webinar, multiple histone PTMs, including H3K27 trimethyl were elevated in subsets of patients. In this context, Nu.Q assays could serve as minimally invasive liquid biopsy tools to preselect those patients who are more likely to benefit from specific epidrugs.
Great. And then we have some questions for Marielle. So I wanted to first ask, is this an immunoassay or a sequencing-based assay?
It's an immunoassay. It's a sandwich immunoassay using a capture antibody that is specific to some epigenetic feature and an anti-nucleosome antibody in detection. So it is sandwich immunoassay.
And another one for you. Someone asked, how specific is the antibody to detect H3K27e3 versus monoenzymal dilation?
Thank you. It's a really good question. In fact, you should know that one of the first experiments we did when we developed an assay is to check the specificity and we rejected a lot of antibody there. And for the H3K27Methyl3 Nu.Q immunoassay, we have checked the cross-reactivity with non-methylated mono or di, and there is no cross-reactivity with those histone modification. So H3K27Methyl3 is really specific to this premethylated mark.
And then one more for you, Marielle. What are the logistical considerations for sample collection, shipping and processing, especially when using the Nu.Q in global clinical trials?
Yes. So indeed, there are some [indiscernible] condition or sample processing. Obviously, it will also depend on the Matrices. As we mentioned at the beginning, we can work on Nu.Q assay can be used in different type of matrices, tissue, blood and so on. But just as a first, our experts are available to discuss with you and to guide you.
But as example, for K2EDTA plasma sample, we recommend to centrifuge blood within the first 4 hours and then to store either at 4 degrees for immediate testing or if you want to ship us, it has to be stored and shipped on ice because they have to be stored on minus 80 degrees.
The other recommendation is also to avoid multiple freezestore cycles. So it's much better to have 1 or maximum 2 freezestore cycles before analyzing your blood samples, for example.
And another for you, Marielle, somebody asked, is the [indiscernible] test FDA approved?
Not yet. This test is a research use only test from now.
Great. And we'll pop back to Eric, a question for you. How do Nu.Q assays integrate with complementary biomarker modalities such as ctDNA and circulating tumor proteins to track responses to therapeutics?
Sure. Nu.Q assays can be integrated with other biomarker platforms that use blood such as genomic and proteomic liquid biopsy assays. And this provides a more comprehensive view of tumor biology and treatment response. A compelling example comes from the non-small cell lung cancer story presented here, where ctDNA sequencing identified 43.1% of patients undergoing treatment.
In parallel, Nu.Q assays targeting histone PTM such as H3K27 trimethyl detected additional patients, capturing 15.1% of cases not identified by ctDNA alone. This demonstrates Nu.Q assays can serve as complementary tools to ctDNA sequencing, improving sensitivity in detecting circulating tumor material and enhancing the overall ability to monitor tumor responses or recurrence of minimal residual disease.
In addition, Nu.Q assays can complement existing circulating protein tumor markers. For example, tumor protein markers like CEA in colorectal, breast, lung and GI cancers or CA125 in ovarian cancer or PSA in prostate cancer are commonly used to monitor treatment response.
Given that EZH2 is a prognostic factor across these tumor types, the Nu.Q H3K27 trimethyl assay could potentially identify patients not captured by these traditional tumor markers. This combination can broaden the range of patients effectively monitored by liquid biopsy, particularly in cancers with heterogeneous expression profiles.
Okay. Great. And I have another question for Marielle. Someone asks, is there any contamination from this based on ethylation protein other than from nucleosome? Do you need an enrichment step to enrich nucleosomes from plasma samples?
Thank you for this question. So our sandwich immunoassay are designed to detect intact circulating nucleosome. So we are not detecting any free histone. We are really detecting circulating nucleosome with a specific histone PTMs. That's for the first part of the question.
And for the second part, no, we do not enrich our sample. You can use directly 50 microliter of plasma sample in the immunoassays. So there is no enrichment, you use directly plasmas.
And Marielle, while I have you, can you talk a little bit about how Volition supports pharma partners in customizing these assays or developing new biomarkers that are tailored to specific drug programs?
Yes, for sure. So another very good question. So definitely we can support and customize assay, for example, different matrices that we have not explored yet. And we are there to help to maybe optimize assays to design protocols that would work for these new matrices, for example.
But we are also really open to work for and to develop new assay for our new Histone PTM that we have not targeted yet in our portfolio. For this, we have really a team that is dedicated to assay development. They have already developed a 14 assay present in our current portfolio. So they have -- they are highly -- have a huge expertise to assay development. So we are really there and to be open to discuss with you to support your histone PTM research and really to customize any assays.
And then a question for Eric. How do you -- how do EZH inhibitors improve immunogenicity of tumor cells for immunotherapy?
Thank you for that question. For this, I did prepare a slide. So EZH inhibitors reverse epigenetic mediated gene repression. This leads to increased tumor visibility to the immune system and supports T cell infiltration and activation. Exciting emerging data now show that EZH inhibition also significantly enhances the efficacy of adoptive cell therapies, including CAR-T and TCR-engineered T cells across both hematologic malignancies and solid tumors.
EZH inhibition does this by increasing tumor immunogenicity, which in turn supports T cell activation, persistence and function. As shown in 2 recent 2025 preclinical studies published in cancer cell and summarized here schematically, EZH inhibition reprograms tumor cells through reduction of H3K27 trimethyl marks resulting in upregulation of MHC proteins, co-stimulatory ligands and adhesion molecules. EZH inhibition also increases inflammatory cytokine production. These reprogramming changes make tumor cells more visible, leading to improved recruitment and engagement of CAR-T and TCR-engineered T cells, which makes the tumor cells more susceptible to T cell-mediated killing.
In lymphoma models, EZH inhibition not only enhance infiltration of CAR T cells, but also prolong interaction between T cells and tumor cells, improving cytotoxicity.
Additionally, pretreating CAR T cells with EZH2 inhibitors improve their stemness, expansion and resistance to exhaustion, enabling better in vivo persistence and sustained antitumor activity. Importantly, dual EZH1/2 inhibition, for instance, with valemetostat showed even greater enhancement of adoptive cell therapy across a range of tumor antigens and cancer types, including solid tumors.
Overall, EZH2, EZH inhibition acts on both tumor cells and T cells, reprogramming the tumor microenvironment to be more permissive to immune attack and supporting durable responses to adoptive cell therapies. Ongoing clinical trials are now evaluating these combinations in relapsed/refractory lymphomas and other malignancies. Thank you.
Thanks, Eric. I'm going to hop back to Marielle. We have someone in the audience just wondering, do we need to do the centrifugation twice for plasma separation or is one time enough?
No. For the plasma preparation, we do not need -- you do not need to do twice centrifugation. You can do 1 or 2 centrifugation as you are used to. Anyway, the Nu.Q assay step include another centrifugation before running the assay, so basically, you can do 1 or 2 centrifugation depending on your current protocols for plasma.
Great. So thank you both. That's all the time we have for today. So I'd like to thank Eric and Marielle and our sponsor Volition. If we didn't get to them -- if we didn't get to your question, we'll try to follow up with our experts, and they'll be able to get back to you. But thank you, everyone, for your questions.
And as a reminder, please look out for the survey after you log out to provide your feedback. If you missed any part of this webinar or would like to listen to it again, an archived version will be e-mailed to all attendees. Thank you for joining us for this Genome webinar.
Financial data from VolitionRX
Revenue
Revenue is the sum of all sales generated by a company, e.g. for its products or services.
Revenue (TTM) metric explainedDirect Costs
Direct costs are the costs incurred directly in connection with the manufacture of the product or service.
Gross Profit
Gross Profit indicates how much of the revenue remains in the company after deducting direct production costs. If the percentage share of sales is calculated, this is referred to as the gross margin.
Gross Profit metric explainedSelling and Administrative Expenses
Selling, general and administrative expenses (SG&A) include all expenses for marketing and sales as well as the general administration of the company.
Research and Development Expense
Research and development costs (R&D) provide information on how much the company invests in the research and development of its products. The costs are particularly interesting as a percentage of revenue and in comparison to direct competitors.
EBITDA
EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization) is the company's earnings before interest, taxes, depreciation and amortization. The EBITDA margin is calculated as a percentage of sales.
Depreciation and Amortization
Depreciation represents reductions in the value of the company's assets (e.g. due to wear and tear on machinery).
EBIT (Operating Income)
EBIT (Earnings Before Interest and Taxes) is the company's profit before interest and taxes, also known as the operating income. The EBIT Margin is calculated as a percentage of sales at
.
Net Profit
Net Profit represents the profit or loss after deduction of all costs.
Net Profit metric explainedStocksGuide Premium
| Jun '26 |
+/-
%
|
||
| Revenue | 2.46 2.46 |
86%
86%
100%
|
|
| - Direct Costs | - - |
-
-
|
|
| Gross Profit | - - |
-
-
|
|
| - Selling and Administrative Expenses | 12 12 |
7%
7%
501%
|
|
| - Research and Development Expense | 8.45 8.45 |
18%
18%
343%
|
|
| EBITDA | -18 -18 |
18%
18%
-744%
|
|
| - Depreciation and Amortization | 1.11 1.11 |
13%
13%
45%
|
|
| EBIT (Operating Income) EBIT | -19 -19 |
17%
17%
-790%
|
|
| Net Profit | -26 -26 |
10%
10%
-1,042%
|
|
In millions USD.
Don't miss a Thing! We will send you all news about VolitionRX directly to your mailbox free of charge.
If you wish, we will send you an e-mail every morning with news on stocks of your portfolios.
VolitionRX Stock News
Company Profile
VolitionRX Ltd. engages in the development of blood-based cancer tests to help diagnose a range of cancers. Its products include the Nucleosomics platform that identifies and measures nucleosomes in the bloodstream or other bodily fluids. The company was founded on September 24, 1998 and is headquartered in Henderson, NV.
StocksGuide Premium
| Head office | United States |
| CEO | Mr. Reynolds |
| Employees | 75 |
| Founded | 1998 |
| Website | volition.com |
