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VolitionRx(VNRX)2026年第2四半期決算説明会:Nu.Qパイプラインの進展でコスト削減

TradingKeyAug 14, 2026 8:05 PM
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VolitionRxの2026年第2四半期売上高は前年同期並みの約40万ドルとなったが、上半期売上高は同112%増の140万ドルに拡大した。コスト削減策により営業費用は同32%減少したものの、非現金会計費用が影響し最終赤字は730万ドルに拡大した。製品開発面では、「Nu.Q NETs」の指先採血プロトタイプが約90%の相関性を示し、「Nu.Q 肺がん」のフランスにおける保険償還申請を目指すなど、各プロジェクトが進行している。通期では売上成長を見込み、ライセンス契約の締結を最優先事項として推進している。

AI生成要約

主なポイント

  • VolitionRx Limited(NYSE American: VNRX)が発表した2026年第2四半期売上高は約40万ドルとなり、2025年第2四半期からほぼ横ばいでした。上半期の売上高は前年同期比112%増の140万ドルに増加しました。
  • 第2四半期の営業費用は、同社のコスト削減プログラムや前年同期比27%の人員削減を反映し、670万ドルから32%減の460万ドルに減少しました。
  • 最終赤字は630万ドルから730万ドルに拡大しましたが、これは主にLindの転換社債に関連する約300万ドルの非現金会計費用によるものです。
  • 指先採血によるイムノクロマト法(ラテラルフロー)プロトタイプ「Nu.Q NETs」は、敗血症が確認された重症患者の検体において、CEマーク取得済みの自動アッセイと約90%の相関性を示しました。
  • 経営陣は2026年第3四半期中にフランスで「Nu.Q 肺がん」の保険償還申請を目指しているものの、保険償還の承認は引き続き不確実であると強調しています。
  • 「Nu.Q Vet」猫がん研究の論文掲載により、500万ドルの契約上のマイルストーン支払いが発生すると見込まれています。このプロトタイプは97%の特異度で猫のリンパ腫の86%を検出しました。

主な財務データ

指標2026年第2四半期2025年第2四半期変動 / 備考
売上高約40万ドル約40万ドルほぼ横ばい。「Nu.Q Vet」の増収分が「Nu.Q Discover」サービス売上の減少によって相殺
上半期売上高140万ドル前年同期比112%増
営業費用460万ドル670万ドル前年同期比32%減
営業赤字前年同期比34%減
最終赤字730万ドル630万ドル主にLind社債関連の約300万ドルの非現金費用を反映して赤字拡大
営業活動によるキャッシュ・フロー(使用額)520万ドル630万ドルコスト削減効果が出始め、前年同期比で減額
現金および現金同等物280万ドル110万ドル(2025年12月31日時点)第2四半期の資金調達には、ATM増資枠からの120万ドルおよび公募増資からの410万ドルが含まれます

経営陣によると、第2四半期の売上高は繰延収益と製品売上高にほぼ等分されました。繰延収益の計上はHeska社との契約に関連しており、契約期間中に獣医向け検査薬が出荷されるに伴って行われます。

事業および業績

Nu.Q NETsと敗血症

VolitionRxは、ポイント・オブ・ケア(POC)向けイムノクロマト法プロトタイプのさらなる進展を報告しました。指先採血によるアッセイは、集中治療室の確定敗血症患者の検体において、同社の自動化CEマーク取得済み「Nu.Q NETs」アッセイと約90%の相関性を示しました。

経営陣は、イムノクロマト法フォーマットを中央検査室での検査を補完するものと見ています。想定される用途には、病院での迅速検査、在宅検査、検査インフラが限られた低所得国での展開などが含まれます。

同社は、3つの独立した病院での臨床検証に先立ち、本アッセイを研究用(RUO)ステータスに進める計画であり、臨床検証は2027年初頭に開始したいと考えています。また、経営陣はジラリ・アナンヌ教授のチームによる1,000人以上の患者を対象とした研究を完了させ、2026年9月にフランス政府支援のDETECSEPSプログラムを開始することを見込んでいます。Nu.Q NETsは同プログラムの唯一のバイオマーカーです。

VolitionRxはまた、さらなる外傷研究のため、メイヨークリニックに自動分析装置「IDS i10」を供給しています。引用されたメイヨークリニックの研究には674名の外傷患者が含まれていました。H3.1の平均濃度は、健常者で1ミリリットルあたり22.3ナノグラム、外傷患者で359.7ナノグラム、その後に静脈血栓塞栓症を発症した患者で828.4ナノグラムでした。経営陣は、2026年第3四半期中に分析装置がメイヨークリニックに設置されると予想しています。

これとは別に、シスメックスはNETosisに関連する疾患向けに、自社プラットフォーム上でのNu.Q NETsの最適化を開始しました。VolitionRxはまた、抗リン脂質抗体症候群についてウェルフェン(Werfen)との協業を継続しています。

Nu.Q 肺がん

同社の短期的な最優先事項は、フランスにおいて「Nu.Q 肺がん」の保険償還を取得することです。VolitionRxは事前の初回協議を終えており、2026年第3四半期中にフォローアップ協議と申請を行う予定です。

経営陣は、このプロセスに関する最初の進展情報が2026年後半に入ると予想しており、順調に進めば2027年にフランスで日常的な臨床利用が可能になると見込んでいます。その他に計画されている取り組みには、リヨン公立病院(Hospices Civils de Lyon)との最終検証研究、国立台湾大学チームによる新たな臨床論文、および微小残存病変に関する更なるエビデンス収集が含まれます。

Capture-Seq

四半期末以降に、VolitionRxの「Capture-Seq」リキッドバイオプシー技術を説明した査読付き論文が掲載されました。この手法はCTCF結合DNAを物理的に濃縮し、バイオインフォマティクスを用いてバックグラウンドとなる非腫瘍由来の游離DNA(cfDNA)配列をほぼすべて除去します。

同社は、がんマルチ早期発見および微小残存病変への応用可能性を評価しています。経営陣は、技術の有効性が実証された場合の獲得可能な最大市場(TAM)を、それぞれ年間約230億ドル、130億ドル以上と試算しています。複数のリキッドバイオプシー企業および診断薬企業との間で、技術評価やライセンス交渉が進行中です。

Nu.Q Vet 猫がん検査

VolitionRxは猫がん研究を査読に提出しました。プロトタイプアッセイは特異度97%で猫のリンパ腫の86%を検出しました。同社は、これが猫がん向けの初の手軽で手頃な価格の血液ベースのリキッドバイオプシー検査になり得ると考えています。

論文掲載により、500万ドルの契約上のマイルストーン支払いに関する同社の義務が満たされる見込みです。経営陣は、査読プロセスに期待以上の時間がかかっているものの、掲載は時間の問題であると述べています。

業績予想(ガイダンス)

四半期ごとの売上高が引き続き不均一で予測が困難なため、VolitionRxは2026年の売上高ガイダンスを提供しませんでした。プロジェクトのタイミング、大型の製品注文、および「Nu.Q Discover」の収益認識は、一部パートナーのスケジュールに依存しています。

それにもかかわらず、経営陣は2026年通期での売上成長を見込んでおり、繰延収益と製品売上高のほぼ50対50の分割が年内残りの期間も続く可能性があることを示しました。同社はまた、2026年中にさらなるコスト削減を計画しています。

同社の商業化戦略は、大規模な自社直販診断インフラを構築するのではなく、ライセンス契約に焦点を当て続けています。経営陣によると、VolitionRxはウェルフェン(Werfen)、シスメックス(Sysmex)、レビティ(Revvity)、ホロジック(Hologic)と契約を結んでおり、さらに10社以上の診断薬・リキッドバイオプシー関連企業と協議を進めています。

リスクおよび注目点

  • 製品出荷や「Nu.Q Discover」プロジェクトの時期についての視界が限られているため、売上高は引き続き不規則に変動する見込みです。
  • フランスにおける「Nu.Q 肺がん」の保険償還は保証されておらず、経営陣は保険償還プロセスにリスクが伴うことを明示的に示しています。
  • イムノクロマト法「Nu.Q NETs」アッセイには、依然として追加の品質管理、臨床検証、および地域ごとの規制対応作業が必要です。
  • 猫がんに関する500万ドルのマイルストーン受領の時期は査読付き論文の掲載にかかっており、経営陣が当初想定していたよりも時間がかかっています。
  • ATM増資枠および株式・新株予約権の公募による手取金調達を経て、第2四半期末の現金および現金同等物は280万ドルとなりました。

アナリストQ&Aの要点

アナリストは、中央検査室でのアッセイに対するイムノクロマト法「Nu.Q NETs」検査の役割に焦点を当てました。経営陣は、POCフォーマットは検査室での検査に置き換わるものではなく、救急医療、在宅検査、インフラが不十分な市場へと利用を拡大できると述べました。

猫がんに関して、経営陣は猫の通院頻度が犬よりも低いため商業市場は犬向け市場より小さい可能性があると指摘しました。しかし、世界全体で年間数百万件から数千万件の検査需要の可能性があると見ています。

フランスでの肺がんの保険償還に関し、経営陣はプロセスが米国の制度とは大きく異なると述べました。同社は進展具合に満足しているものの、承認が確実であるとは見なしていません。

「Nu.Q Discover」について、経営陣は第2四半期の売上減少がパイプラインの縮小ではなくプロジェクトのタイミングによるものであると説明しました。収益認識は、パートナーが臨床試験やその他のプロジェクトを開始する時期に引き続き依存します。

決算説明会トランスクリプト全文


決算説明会の完全なトランスクリプト

経営陣による説明

Operator

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.

Louise Batchelor Day

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.

Cameron Reynolds

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.

Terig Hughes

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.

Cameron Reynolds

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

[Operator Instructions] And our first question will come from Michael Okunewitch with Maxim Group.

質疑応答

Michael Okunewitch

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?

Cameron Reynolds

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.

Michael Okunewitch

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?

Cameron Reynolds

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.

Michael Okunewitch

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.

Cameron Reynolds

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.

Operator

And our next question will come from Justin Walsh with JonesTrading.

Justin Walsh

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?

Cameron Reynolds

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.

Operator

We'll go next to Yi Chen with H.C. Wainwright.

Unknown Analyst

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?

Cameron Reynolds

Terig, do you want to run through that question.

Terig Hughes

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?

Unknown Analyst

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?

Terig Hughes

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.

Operator

And our next question will come from Bruce Jackson with StoneX.

Bruce Jackson

First, could we get an update on the projects that are ongoing in Taiwan?

Louise Batchelor Day

You want me to take that, Cam?

Terig Hughes

I think Cam might have dropped off.

Louise Batchelor Day

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.

Bruce Jackson

Okay. And then in terms of the feline milestone payment, what's your latest thinking on the timing of receiving that?

Terig Hughes

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.

Operator

And we'll go next to Steven Ralston with Zacks.

Steven Ralston

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?

Louise Batchelor Day

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.

Cameron Reynolds

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?

Steven Ralston

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?

Cameron Reynolds

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?

Steven Ralston

Yes. Thank you for the very meaty explanation of your pipeline here in the near future.

Operator

And we'll go next to Ilya Zubkov with Freedom Capital Markets.

Ilya Zubkov

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?

Cameron Reynolds

Terig, do you want to answer that?

Terig Hughes

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?

Operator

And that concludes our question-and-answer session. I would like to turn the floor back over to Cameron Reynolds for closing comments.

Cameron Reynolds

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.

Operator

Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may disconnect your lines, and have a great day.

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