Q1 2025 VolitionRx Ltd Earnings Call

Yeah.

Operator: Good morning, ladies and gentlemen. Thank you for standing by.

Speaker Change: Good morning, ladies and gentlemen, thank you for standing by.

Operator: Welcome to VolitionRX Limited's First Quarter 2025 Earnings Conference. During today's presentation, all parties will be in a listen-only mode. Following the presentation, there will be a conference call.

Speaker Change: Welcome to volition, our actions are limited first quarter 2025 earnings conference call.

Speaker Change: During todays presentation, all parties will be in a listen only mode. Following the presentation there'll be a conference.

Operator: There will be a question and answer. If you have questions, please press the star key followed by the number 1 on your touch tone phone. If you would like to withdraw your question, please press the star key followed by the number you see on your screen. If you are using speaker equipment, please lift the handset before making your selection.

Speaker Change: There will be a question and answer session.

Speaker Change: You have questions. Please press the star key followed by the number one on your Touchtone phone.

Speaker Change: If you'd like to withdraw your question. Please press the star key followed by the number two.

Speaker Change: If you are using speaker equipment, please lift the handset before making their selections.

Operator: This conference is being recorded today, May 16th, 2021.

Speaker Change: This conference is being recorded today may 16th 2025.

Louise Batchelor: I'd 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 Ltd.

Speaker Change: I'd now like to turn the conference over to Louise Bachelor Group, Chief Marketing and Communications Officer. Please go ahead.

Speaker Change: Thank you.

Speaker Change: Connect me one.

Speaker Change: Days earnings conference call because it is shneur accelerated.

Louise Batchelor: 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 harbour 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.

Speaker Change: 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.

Speaker Change: These statements are based on current beliefs.

Speaker Change: That's why there's assumptions in your view based upon information currently available to us.

Speaker Change: Because these statements reflect our current views concerning future events. These statements involve risks uncertainties and assumptions.

Speaker Change: Actual future results may vary significantly based on a number of certain tests that make holes. They told me so or that's been materially different from future results performance or achievements expressed or implied by these statements.

Louise Batchelor: 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.

We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K.

Speaker Change: Fortunately pools, I'm Form 10-Q, and other filings with the Securities and Exchange Commission.

Speaker Change: Do you have to undertake an obligation to update any forward looking statements made during the course of this call.

Louise Batchelor: Terig Hughes, Chief Financial Officer, will open the call with a full financial report before handing over to Cameron Reynolds, Group Chief Executive Officer, for a business update and discussion of upcoming milestones.

Kevin Keyes: Kevin Keyes, Chief Financial Officer, well April Nicole with a full financial report beforehand and gave it to come in Nano group Chief Executive Officer for a business update and discussion of upcoming launch dates. We will then open the conference call to a question answer session and with that I'll turn the call over to Terry.

Louise Batchelor: We will then open the conference call to a question and answer session.

Terig Hughes: And with that, I'll turn the call over to Terig. Thanks Lou and thank you everyone for joining Volition's first quarter 2025 earnings call today. We appreciate your time given the busy earnings season. As stated on our last call, one of our key financial goals for 2025 is to be cash-neutral on a full-year basis, meaning income, including licensing receipts, matches expenditure on a cash basis, and I'm delighted to report that across a range of financial indicators we made significant progress towards this target during this quarter. Total operating expenses for the quarter declined 35% compared to the first quarter of 2024.

Speaker Change: Thanks, Luke and thank you everyone for joining Volitions first quarter 2025 earnings call. Today. We appreciate your time given the busy earnings season.

Speaker Change: As stated on our last call one of our key financial goals for 2025 is to be cash neutral on a full year basis, meaning income, including licensing receipts matches expenditure on a cash basis and I'm delighted to report that across a range of financial indicators, we made significant progress towards this target during this quarter.

Speaker Change: Total operating expenses for the quarter declined 35% compared to the first quarter of 2024.

Terig Hughes: This reflected cost reductions across all spending categories. As a result of the strong cost management, net cash used in operating activities was $4.3 million for the first quarter, compared to $8.3 million in quarter one of 2024. Revenue-wise, we recorded almost a quarter of a million dollars of revenue in the quarter, a growth of 44% over the first quarter of 2024, including the first revenue recorded for sales of a human product, a great milestone. It is worth noting, as we have stated previously, that at this early stage of commercialisation, revenues remain fairly lumpy and difficult to predict from one quarter to the next.

Speaker Change: This reflected cost reductions across all spending categories.

Speaker Change: As a result of the strong cost management net cash used in operating activities was $4 3 million for the first quarter compared to $8 3 million in quarter. One of 2020 for revenue wise, we recorded almost quarter of a million dollars of revenue in the quarter a growth of 44% over the first quarter of 2024 <unk>.

Speaker Change: <unk> the first revenue recorded for sales of human product a great milestone.

Speaker Change: It is worth noting as we have stated previously that at this early stage of commercialization revenues remained fairly lumpy and difficult to predict from one quarter to the next so while we remain confident is seeing solid growth on a full year basis, we will not be providing revenue guidance for 2025 at this point in time.

Terig Hughes: So while we remain confident of seeing solid growth on a full year basis, we will not be providing revenue guidance for 2025 at this point in time. Cash and cash equivalents at the end of the quarter totaled approximately $2.6 million compared to $3.3 million at the end of 2024. Receipts during the first quarter included $2.3 million from a registered direct offering $1.6 million in non-dilutive loan finance. and $0.2 million in grant receipts.

Speaker Change: Cash and cash equivalents at the end of the quarter totaled approximately $2 $6 million compared to $3 $3 million at the end of 2024.

Speaker Change: Receipts during the first quarter included $2 $3 million from a registered direct offering.

Speaker Change: One $6 million in non dilutive loan financing and O point $2 million in grant proceeds.

Terig Hughes: Subsequent to quarter-end, we finalised a convertible loan note to provide $6.25 million in gross proceeds, repayable in cash or shares, over 24 months, with an initial six-month repayment holiday.

Speaker Change: Subsequent to quarter end, we finalize the convertible loan note to provide six point to $5 million in gross proceeds repayable in cash or shares over 24 months with an initial six month repayment holiday.

Terig Hughes: So, to summarise the finance report, key indicators are trending positively. Revenue was up 44% year-on-year, including our first ever revenue for use of our new Q technology in humans. Total operating expenses were down 35% year-on-year. Cash used in operating activities was down 48% compared to Q1 2024. We continue to receive non-dilutive funding support in the form of grants and loans from Belgian institutions. And last but not least, licensing discussions are progressing well. These items combined support our goal to be cash flow neutral for full year 2025.

Speaker Change: So to summarize the financial board key indicators are trending positively.

Speaker Change: Revenue was up 44% year on year, including our first ever revenue for use of our new <unk> technology in humans.

Speaker Change: Total operating expenses were down 35% year on year.

Speaker Change: Cash used in operating activities was 10, 48% compared to Q1 2024.

Speaker Change: We continue to receive non dilutive funding support in the form of grants and loans from Belgian institutions.

Speaker Change: And last but not least licensing discussions are progressing well.

Speaker Change: These items combined support our goal to be cash flow neutral for full year 2025.

Cameron Reynolds: And with that, I will pass over to Cameron for a business update.

Speaker Change: And with that I will pass over to Cameron for a business update.

Cameron Reynolds: Cameron. Thank you, Terig, and good morning, everyone. 2025 is a pivotal year for Volition as we focus on commercializing our groundbreaking NUQ platform in the human diagnostic market. I'm delighted to report we are in confidential discussions with over 10 companies to license our products. Notably, the combined market value of seven of these companies exceeds $600 billion, underscoring the significant global strength, potential reach and impact our technology could achieve through such partnerships. Our goal is to secure multiple licensing agreements in the human diagnostic space, mirroring our successful strategy in the veterinary market with diverse deal structures, all with ongoing revenue, and some to include large milestone payments.

Cameron: Thank you Terry and good morning, everyone 2025 is a pivotal year for volition as we focus on commercializing our groundbreaking new key platform in the human diagnostic market I'm delighted to report we are in pump potential discussions with over 10 companies to license our products, notably.

Cameron: The combined market value of seven of these companies exceed $600 billion underscoring the significant global strength potential reach and impact of our technology could achieve three such partnerships. Our goal is to secure multiple licensing agreements in the human diagnostic space mirroring.

Cameron: Our successful strategy in the veterinary market with diverse deal structures, all with ongoing revenue and some to include large milestone payments.

Cameron Reynolds: Our strong clinical evidence supports the broad applicability of our new Q-Technology in critical areas such as cancer and sepsis. These two disease areas alone represent a combined total addressable market of about $25 billion annually, offering substantial revenue opportunities for Volition and our future partners. As a reminder, all the pillars use almost exactly the same Neutrosome technology. making it extremely effective in both cancer and sepsis for human and animal health use. Volition is a company powered by NUQ and focused on one thing, measuring chromatin fragments in circulation. This one thing is the basis of all of our pillars.

Cameron: Our strong clinical evidence supports the broad applicability of our <unk> technology in critical areas, such as cancer and sepsis.

Cameron: These two disease areas alone represent a combined total addressable market of about $25 billion annually.

Cameron: I'll bring substantial revenue opportunities for volition and all future partners.

Cameron: As a reminder, all the pillars use almost exactly the same nucleosome technology.

Cameron: Making an extremely effective in both cancer and sepsis for human and animal health use.

Cameron: Volition is a company powered by new cube and focused on one thing measuring perimetry fragments in circulation.

Cameron: This one thing is the basis of all of our pillars.

Cameron Reynolds: We now can measure nucleosomes on around half a dozen different established collaborator platforms. The broad applicability of what we have developed is, I believe, completely unprecedented.

Cameron: We now can measure nucleus homes on around half a dozen different establish collaborate our platforms.

Cameron: The broad applicability of what we have developed is I believe completely unprecedented.

Cameron Reynolds: Taking each pillar in turn, I will start with cancer. We are making significant strides in the commercialization of our cancer diagnostic pillar. From a licensing perspective, I am pleased to report that two major companies are currently in active negotiations and have either commenced or planning to commence the evaluation of our innovative NuQ and CaptureSeq technologies. with first results anticipated within the next quarter. Two incredibly exciting projects to look out for. Furthermore, our pivotal final lung cancer screening study in Taiwan is progressing very rapidly with more than 100 patients already enrolled. The National Taiwan University Hospital, NTU, team is making great progress and aims to present interim analysis at the European Society of Medical Oncology Congress in October.

Cameron: Taking each pillar and 10 I will start with cancer.

Cameron: We are making significant strides in the commercialization of our cancer diagnostic pillar.

Cameron: From a licensing perspective I am pleased to report that two major companies are currently in active negotiations have commenced or planning to commence the evaluation of our innovative new cute and capture seek technologies.

Cameron: With first results anticipated within the next quarter.

Cameron: Two incredibly exciting projects to look out for.

Cameron: Furthermore, our pivotal find a lung cancer screening study in Taiwan is progressing very rapidly with more than 100 patients already enrolled.

Cameron: The National Taiwan University Hospital and to you team is making great progress and aims to present interim analysis at the European Society of medical Oncology Congress in.

Cameron: Tiber.

Cameron Reynolds: Positive findings could position our new Q-Test for inclusion in national lung cancer screening programs representing a potential market exceeding $1 billion across Taiwan, the US, UK and France alone. And this could be implemented relatively quickly in several countries, assuming UQ cancer is made available as a lab-developed test with no further need for regulatory studies. We are making significant headway in the commercialisation of new QNets as well.

Cameron: Positive findings could position on Youku test for inclusion in national lung cancer screening programs, representing a potential market exceeding $1 billion across Taiwan U S U K and France alone.

Cameron: And this could be implemented relatively quickly in several countries assuming NICU cats that is made available as a lab developed test with no further need for regulatory studies.

Cameron: We are making significant headway in the commercialization of <unk> units as well we have a two pronged strategy. The first prong of our strategy is licensing to large international players.

Cameron Reynolds: We have a two-pronged strategy. The first prong of our strategy is licensing to large international players. Licensing discussions are progressing well, with several potential licensing companies having already successfully completed the tech transfer of our assay onto their platforms. Our extensive clinical evidence supports the use of our NUQ-NETS technology in a critical area – sepsis. The total addressable market for the testing and monitoring of intensive care patients alone represents a $1 billion opportunity annually, offering substantial revenue opportunities for Volition and our future partners. We believe that the total addressable market of our NUQ NETS assay could be in excess of $10 billion annually as the use cases expand far, far beyond SEPSA.

Cameron: Licensing discussions are progressing well with several potential licensing companies, having already successfully completed the tech transfer of our assay onto their platforms.

Cameron: Our extensive clinical evidence supports the use of our nuclear niche technology in a critical area sepsis.

Cameron: The total addressable market for the testing and monitoring of intensive care patients alone represents a $1 billion opportunity annually offering substantial revenue opportunities for volition and our future partners.

Cameron: We believe that the total addressable market about new unit assay could be in excess of $10 billion annually as the use cases expand far far beyond sepsis.

Cameron Reynolds: The second prong of our NUQ-NET commercialisation strategy is to leverage our granted CE mark, which means approved for use in the European Union for any natosis-related diseases. As a reminder, Volition's chemiluminescent immunoassay clear version of the CE-marked MuQ-Nets test is run on the IDS i10 automated analyzer platform from Immunodiagnostic Systems, IDS, a subsidiary of Revity. I would like to thank IDS for their collaborative approach. Our aim is to sell this product, either directly or in conjunction with IDS, to institutions for use in a very wide range of clinical applications where NETS plays an active role.

Cameron: The second prong of our new units commercialization strategy is to leverage our granted CE, Mark which means approved for use in the European Union for any niche hostess related diseases.

Cameron: As a reminder, volitions chemiluminescence immunoassay clear version of the CE Mark each unit's test is run on the ideas I 10 automated analyzer platform from immuno diagnostics systems I D. S. A subsidiary of brevity I would like to thank I D. S for their collaborative approach.

Cameron: Our aim is to sell these products either directly or in conjunction with ideas to institutions for use in a very wide range of clinical applications, where nits plays an active role in our significant commercial milestone we recorded a very first revenue from sales of IC Max units automated product in Europe in Q1 of this.

Cameron Reynolds: In a significant commercial milestone, we recorded our very first revenue from sales of our C-Marked Mew2NETS automated product in Europe in Q1 of this year. This is our very first revenue generated from a regulated, clinically approved product in humans, which is quite a milestone for the company. Nine hospital networks in five countries have placed orders and are currently assessing its clinical utility in a range of NETS applications with the intention, we believe, of integrating it directly into their routine patient care. In addition, we are in discussion with a further 12 hospital networks, with at least nine evaluations anticipated to start in the second half of this year.

Cameron: This is our very first revenue generated from our regulated clinically approved product in humans, which is quite a milestone for the company nine hospital networks in five countries have placed orders and are currently assessing its clinical utility in a range of nets applications with the intention we believe.

Cameron: Of integrating it directly into their routine patient care. In addition, we are in discussion with a further 12 hospital networks with at least nine evaluations anticipated to start in the second half of this year in short a number of hospital groups are buying a CE mark regulatory products with the view to using and clinically.

Cameron Reynolds: In short, a number of hospital groups are buying our C-Marked regulatory products with the view to using it clinically in a diverse range of NETS-related uses. We're absolutely delighted with the level and breadth of interest that we have seen in the past six months, and we continue to receive more inbound inquiries. The range of potential clinical use cases where natosis plays a role is extremely broad. Equating to a mix of potential market sizes, from small to very large, there is clearly wide unmet clinical needs driving these evaluations. Nets are a key part of a very broad range of clinical conditions, and our aim is to become the Nets company worldwide, by partnering with the very best companies, hospital networks and government.

Cameron: In a diverse range of nits related uses.

Cameron: We're absolutely delighted with the level and breath of interest that we've seen in the past six months and we continue to receive more inbound inquiries the range of potential clinical use cases, where the ptosis plays a role is extremely broad equating to a mix of potential market sizes from small to very large.

Cameron: There is clearly wide unmet clinical needs driving these evaluations.

Cameron: Net are a key part of a very broad range of clinical conditions and our aim is to become the next company worldwide by partnering with the very best companies Hospital networks and governments.

Cameron Reynolds: The level of interest in using our new QNets test is notable. Clinical use cases include coagulation, cardiac issues, renal disease, trauma, burns, autoimmune diseases, organ transplants, pregnancy management, and of course, the biggest of them all, being sepsis. This is an amazing outcome for Volition. Customers buy our kits, generating not only revenue, but also clinical data for a wide range of broad clinical use cases. We expect, through this second CEMark sales prong, that our new QNets test will start to be used in routine clinical practice with patients next year in the EU and then expand to use worldwide through the expected global licensing agreements of the first prong of our strategy.

Cameron: The level of interest in using our new Ethernet test is notable clinic.

Cameron: Clinical use cases include coagulation cardiac issues renal disease trauma.

Cameron: Those autoimmune diseases organ transplants pregnancy management and of course, the biggest of them all being sepsis.

Speaker Change: This is an amazing outcomes of volition customers buy our kits generating not only revenue, but also clinical data for a wide range of broad clinical use cases.

Speaker Change: We expect through the second Seamark sales from that our Newquay nets test will start to be used in routine clinical practice with patients next year in EU and then expand to use worldwide through the expected global licensing agreements of the first prong of our strategy.

Cameron Reynolds: Next up, Mew2Vet. Expanding the global reach of our NUQ vet cancer tests remains a key priority, enabling vets worldwide to improve canine cancer screening and outcomes. Our supply agreements with leading industry players including Antec part of the Mars Science and Diagnostics Group, Fujifilm VET Systems and IDEX are instrumental in achieving this. To further accelerate revenue growth and ensure consistent delivery, we have focused on central lab automation.

Speaker Change: Next up new vet.

Speaker Change: Expanding the global reach of our NICU vet cancer tests remains a key priority, enabling vets worldwide to improve cana in cancer screening and outcomes.

Speaker Change: Our supply agreements with leading industry players, including Amtech, which is part of the Mars Science and diagnostics group Fuji film Vet systems and IDEXX are instrumental in achieving this.

Speaker Change: To further accelerate revenue growth and ensure consistent delivery, we are focused on central lab automation.

Cameron Reynolds: In March, Fujifilm VetSystems extended their contract with us to validate and then implement a centralized automated platform for the NUQ-VET cancer test using IDS's i10. This is a world first for us, and we believe that it will significantly enhance turnaround times and throughput to meet increasing demand. We believe the automation of central labs is crucial to accelerating our growth rate, and this has become a particular area of focus for us. We aim to get our large customers automated so that they can easily and effectively handle the much larger number of tests that would result from having our tests in annual PET wellness panels.

Speaker Change: In March Fuji film based systems extended their contract with us to validate and then implement a centralized automated platform for the nuc Youbet cancer tests, using I D S as eitan.

Speaker Change: This is a world first for us and we believe that it will significantly enhance turnaround times and throughput to meet increasing demand. We believe the automation of central labs is crucial to accelerating our growth rate and this has become a particular area of focus for us we aimed to get our large customers automated so that they can easily in effect.

Speaker Change: We handle the much larger number of tests that would result from having our test in annual pet wellness Panel's importantly, this automation platform is the same technology utilized for a human diagnostic products, such as Nishu cancer, New units and you discover highlighting the inherent synergy and efficiency about.

Cameron Reynolds: Importantly, this automated platform is the same technology utilised for our human diagnostic products such as NUQ Cancer, NUQ Nets and NUQ Discover. Highlighting the inherent synergy and efficiency of our core NUKU technology.

Speaker Change: CT nuclear technology.

Cameron Reynolds: Next, our fourth and final pillar, NUQ Discover. Our NuQ-Discover tools provide drug developers and scientists with a range of rapid epigenetic profiling assays across preclinical and clinical development pathways from discovery to market ready. UQ-Discover is built on proprietary nucleosome quantification technology. It is a valuable research tool for R&D professionals working within the field of pharmacoepigenetics, studying the epigenetic basis for variation in response to drugs. The NuQ-Discover pillar spans activities as diverse as supplying research use-only kits, either directly or via our U.S. distributor, Diapharma, to providing services such as sample processing on-site in Belgium and California, either with assays or our recently announced high-throughput screening method.

Speaker Change: Next our fourth and final pillar you discover.

Speaker Change: Our nuclear discover tools provide drug developers and scientists with a range of rapid epigenetic profiling assays across preclinical and clinical development pathways from discovery to market ready.

Speaker Change: You can discover is built on proprietary nucleosome quantification technology. It is a valuable research tool for R&D professionals working within the field of Pharmacopeia epigenetics studying the epigenetic basis for variation in response to drugs.

Speaker Change: Then you can discover pillar spends activities as diverse as supplying research use only kids either directly or via a U S distributor dire pharma to providing services such as sample processing onsite in Belgium, and California, either with assays, all our recently announced high throughput screening method.

Cameron Reynolds: It also spans collaborations with drug developers utilising our assays as a surrogate endpoint or pharmacodynamic marker with a specific drug in development. Following a successful pilot study, we announced this quarter that our NUQ-Discover biomarkers are to be utilised in a human clinical study sponsored by a leading pharmaceutical company for the very first time. This was yet another significant milestone for our NUQ-Discover program, the first human study with a pharmaceutical company sponsor, utilising Volition's biomarkers to measure disease progression and response to treatment in a longitudinal Phase I-IIb trial of an experimental drug. We are delighted to support the pharmaceutical company's clinical efforts in developing new drugs for treatment of a large, unmet clinical need.

Speaker Change: It also spans collaborations with drug developers utilizing our assays as a surrogate endpoint.

Speaker Change: Or pharmacodynamic marker with a specific drug in development.

Speaker Change: Following a successful pilot study, we announced this quarter that our nuclear discover biomarkers are to be utilized in a human clinical study sponsored by a leading pharmaceutical company to the very first time.

Speaker Change: This was yet another significant milestone for our nuclear discover program. The first human study with a pharmaceutical company sponsor utilizing volitions biomarkers to measure of disease progression and response to treatment in a longitudinal phase one to be trial of an experimental drug.

Speaker Change: We are delighted to support the pharmaceutical companies clinical efforts in developing new drugs for treatment of a large unmet clinical need.

Cameron Reynolds: The inclusion of our nucleosome-based biomarkers in this clinical trial demonstrates the growing recognition of their value in clinical development. This first study is expected to generate significant revenue for VolitionRX. We are in further discussions with this and other companies and anticipate additional clinical studies which we believe will not only further validate the capabilities of our technology and strengthen our position in the pharmacoepigenetics market, but also generate future revenue.

Speaker Change: The inclusion of a nucleus AUM based biomarkers in this clinical trial demonstrates the growing recognition of the value in clinical development.

Speaker Change: This first study is expected to generate significant revenue for volition.

Speaker Change: We are in further discussions with this and other companies and anticipate additional clinical studies, which we believe will not only further validate the capabilities of our technology and strengthen our position in the pharma co epigenetics market, but also generate future revenue.

Cameron Reynolds: This approach represents a significant step forward towards Volition's long-term goal of enabling precision therapy for patients. By identifying specific epigenetic signatures associated with disease states and treatment responses, Volition aims to help clinicians match patients with the therapies most likely to benefit them, while sparing them from treatments unlikely to be effective. This application of NucuDiscover in the Phase 1-2b trial demonstrates how Volition's nucleosome expertise is transitioning from research to clinical applications, creating value for pharmaceutical partners while advancing the field of personalized medicine. As this and future studies generate additional data about nucleosome-based biomarkers' predictive and prognostic capabilities, Volition is well positioned to expand its role in precision medicine and target therapeutic approaches.

Speaker Change: This approach represents a significant step forward towards Volitions long term goal of enabling precision therapy for patients.

Speaker Change: Identifying specific epigenetic signatures associated with disease state and treatment responses volition aims to help clinicians match patients with a therapy is most likely to benefit them, while sparing them from treatments unlikely to be effective.

Speaker Change: This application you can discover in the phase one to be trial demonstrates how volitions nucleosome expertise is transitioning from research to clinical applications, creating value for pharmaceutical partners, while advancing the field of personalized medicine.

Speaker Change: As this in future studies generate additional data or about nucleosome based biomarker as predictive and prognostic capabilities volition is well positioned to expand its role in precision medicine and targeted therapeutic approaches.

Cameron Reynolds: Another first this quarter was our first commercial sale of our innovative high-throughput synthetic sepsis model. This unique tool enables precise, real-time measurement of neutrophil extracellular traps, NETs, activation inhibition in whole blood, supporting the development of new sepsis and other NETs-related disease therapies. We're currently in discussions with five other companies to finalise projects, positioning UQ Discover as a key revenue driver this year. With over 10 repeat customers from our new Q-Discover kits and services, we aim to at least double revenue in this pillar in 2025.

Speaker Change: Another first this quarter was our first commercial sales of our innovative high throughput synthetic sepsis model. This unique tool enables precise real time measurement of neutrophils extracellular traps net activation inhibition in whole blood supporting the development of new sepsis and other <unk> related disease.

Speaker Change: <unk> therapies.

Speaker Change: We are currently discussions with five other companies to finalize projects positioning you can discover as a key revenue driver this year.

Speaker Change: With over 10 repeat customers from a nuclear discover kits and services. We aim to have these double revenue in this pillar in 2025 and drawing this call to a close I would just like to add that throughout this first quarter and indeed subsequent to quarter end, we will continue to strengthen our clinical evidence supporting our pillars with presentations at several clinical and scientific.

Cameron Reynolds: In drawing this call to a close, I would just like to add that throughout this first quarter, and indeed subsequent to quarter end, we will continue to strengthen our clinical evidence supporting our pillars, with presentations at several clinical and scientific conferences, and the publication of several important manuscripts. With special thanks to our scientific, clinical, manufacturing, operations, and intellectual property teams for their continued efforts. 2025 is about ensuring multiple licensing deals are signed in human space, and we're making good progress on this. We aim to leverage the valuable insights gained from our licensing and supply negotiations for NUQVET, where we have already received milestone payments of $23 million in addition to the ongoing revenue stream.

Speaker Change: Mrs and the publication of several important manuscripts with special thanks to our scientific clinical and manufacturing operations and intellectual property teams for their continued efforts.

Speaker Change: 2025 is about ensuring multiple licensing deals signed in the human space.

Speaker Change: And we're making good progress on this.

Speaker Change: We aim to leverage the valuable insights gained from our licensing and supply negotiations when you convert where we have already received milestone payments of $23 million. In addition to the ongoing revenue stream.

Cameron Reynolds: The objective to sign multiple human licensing deals is similar to what we previously achieved in the VET space. Deal structure wise, we aim to receive large milestone payments from some of these deals and ongoing revenue from all of them. There is a strong and broad interest in potential out-licensing and or supply agreements for both NuQ Nets and our oncology portfolio, with a range of commercial discussions progressing well with large companies. Discussions are also progressing well with several national lung screening programs. These next few quarters are hugely exciting for our company. I think it's very fair to say that we have now developed a technology platform that has already been a breakthrough in veterinary oncology and we are demonstrating how we will also make a significant contribution to both human oncology and sepsis diagnosis and treatment.

Speaker Change: The objective to sign multiple human licensing deals is similar to what we previously achieved in the vet space deal.

Speaker Change: Structure wise, we aimed to receive large milestone payments from some of these deals and ongoing revenue from all of them.

Speaker Change: There is a strong and broad interest in potential out licensing annual supply agreements for both nuc unit and our oncology portfolio with a range of commercial discussions progressing well with large companies.

Speaker Change: Discussions are also progressing well with several national lung screening programs.

Speaker Change: These next few quarters, a hugely exciting for our company.

Speaker Change: I think that's very fair to say that we have now developed a technology platform that has already been a breakthrough in veterinary oncology and we are demonstrating how we will also make a significant contribution to both human oncology and sepsis diagnosis and treatment.

Speaker Change: We now have evidence to support the use of our platforms across a range of clinical applications with very high unmet needs.

Cameron Reynolds: We now have evidence to support the use of our platforms across a range of clinical applications with very high unmet needs. It is a low-cost, robust, and reproducible platform.

Speaker Change: It is a low cost robust and reproducible platform.

Cameron Reynolds: Now we need to commercialize our technology as quickly and as well as possible to make our technology accessible worldwide. When successful, this will clearly support our mission of saving lives and improving outcomes for millions of people and animals worldwide. Our strategy to achieve this has been to raise as much non-dilutive funding as possible, ramp revenue, reduce expenses and sign commercial deals with large industry players. Completing commercial deals for human indications are the final part of this long journey to complete our mission, and we remain focused on achieving that objective.

Speaker Change: Now, we need to commercialize our technology as quickly and as well as possible to make our technology accessible worldwide.

Speaker Change: When successful this will clearly support our mission of saving lives and improving outcomes for millions of people and animals worldwide.

Speaker Change: Our strategy to achieve this has been to raise as much non dilutive funding as possible ramp revenue reduce expenses and find commercial deals with large industry players completing.

Speaker Change: Completing commercial deals for human indications are the final part of this long journey to complete our mission and we remain focused on achieving that objective.

Operator: Thank you for joining the call today, we very much appreciate it. will now take your questions. Operator. Thank you. As a reminder, if you'd like to ask a question, please press star one on your telephone. Your confirmation tone will indicate your line is in the You may press star 2 if you'd like to remove your question from the.

Speaker Change: Thank you for joining the call today, we very much appreciate it.

Speaker Change: We will now take your questions.

Speaker Change: Operator.

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Speaker Change: For participants using speaker equipment.

Speaker Change: It may be necessary to pick up your handset before pressing the star keys.

Ilya Zubkov: Our first question comes from the line of Ilya Zubkov. with Freedom Broker, please proceed. Good morning. Thank you for taking my question. Good morning.

Speaker Change: Our first question comes from the line of.

Jim Goss: Well he is Jim Goss with freedom broker. Please proceed with your question.

Jim Goss: Good morning, Thank you for taking my question.

Speaker Change: Good morning, So I.

Cameron Reynolds: So I want to start from the operating expenses that remain low this quarter. I'm just curious, is this a comfortable level for Volition to maintain through the rest of the 2025?

Speaker Change: I want to start from the operating expenses that remain low this quarter.

Speaker Change: I'm just curious is this a comfortable level for volition to maintain through the rest of the 2025.

Speaker Change: I'll just have a quick answer and then Derek can give you the detail I think it's very important for us to manage costs were obviously in a very important phase in the commercialization is where we're focused so we need to make sure that we're as lean and.

Terig Hughes: I'll just have a quick answer to that and then Terig can give you the details. I think it's very important for us to manage costs. We're obviously in a very important phase and commercialization is where we're focused. So we need to make sure that we're as lean and putting the money to where it has to go in commercialization and products as possible. But Terig, how sustainable is this and do you think where we're going? Yeah, so this is a continued effort to keep a tight control over costs and we've looked across all cost categories and all spending types and we've made very good progress across the board.

Speaker Change: Putting the money to where it has to go into commercialization and product as possible by Terry how sustainable is this and do you think we were doing yeah. So this is ed.

Speaker Change: Continued effort to keep a tight control over costs and we've looked across all cost categories in all spending types and we've made very good progress across the board and yet. This is a this is a focus for the rest of the year. So we'll be looking to keep costs and certainly.

Terig Hughes: And, yeah, this is a focus for the rest of the year. So we'll be looking to keep costs certainly lower than the prior year comparative. So, yeah, this is sustainable. And it's something we take very seriously. There's been a lot of feedback from shareholders. For a company doing what we do, there are other companies in our space that burn through hundreds of millions of dollars a year. That's obviously not what we want to do and we can keep a very low cost model because we're licensing to big players, they do the lab work, they have their own machines and we're looking to get them to the regulatory studies on their machines.

Speaker Change: Lower than the prior year comparative.

Speaker Change: Yes. This is this is sustainable.

Speaker Change: And it's something we take very seriously theres been a lot of feedback from shareholders.

Speaker Change: For a company doing what we do there are other companies in our space to burn through hundreds of millions of dollars a year.

Speaker Change: That's obviously not what we want to do and we can keep a very low cost model because we.

Speaker Change: We licensing to big players they do the lab work they have their own machines and.

Speaker Change: And we're looking to get them through the regulatory studies on their machines. So I certainly our aim is to keep it low and we're not really looking at adding any big things on because we really understand where the market is at the moment and what we need to do to make sure. We keep control of costs and Thats something that <unk> done a very good job of and I take very seriously. So we expect to keep it live.

Cameron Reynolds: So certainly our aim is to keep it low and we're not really looking at adding any big things on because we really understand where the market is at the moment and what we need to do to make sure we keep control of costs. And that's something that Terig's done a very good job of and I take very seriously. So we expect to keep it low. Thank you.

Speaker Change: Thank you and one more question if I may could you provide an update on the progress of the few lines cancer test that is expected to generate a milestone payment.

Cameron Reynolds: And one more question, if I may, could you provide an update on the progress of the feline cancer test that is expected to generate a milestone? Yeah, absolutely. Actually, that's an interesting one. So we've done a lot of work on that. And obviously, this would be our third species. So it's a big milestone for us, apart from the product and the money. I'm very happy to be able to say we've actually the next step was getting pre-analytics in cats working. Now that paper has been published, I believe. It's been accepted. Oh, it's been accepted. So it'll be published soon.

Speaker Change: Yeah, absolutely actually that's an interesting one so we've done a lot of work on that and obviously this will be our third species. So it's a big milestone for us apart from the product and the money.

Speaker Change: I am very happy to be able to say we've actually the next step was getting pre analytics and cats are working on now that paper has been published I believe.

Speaker Change: Oh, it's been accepted to be published soon that the next step and now we're moving onto the clinical data. So it's been a steady process we had to show.

Cameron Reynolds: That's the next step. And now we're moving on to the clinical data. So it's been a steady process. We had to show cats have quite a different blood and less of it, obviously, than a human or a dog. So we had to get the limit of quantification down and the pre-analytics, which doesn't sound very important, but anyone who works in the lab knows it's absolutely critical to actually doing a proper clinical study with valid results. So that's all been done now, and that'll be published soon. So yes, we're making good progress. That's great.

Speaker Change: Have a quite a difference.

Speaker Change: Blood and less of it obviously than a human or Don So we had to get the limit of quantification down and the pre let pre analytics, which doesn't sound very important but anyone who works in the lab nodes is absolutely critical.

Speaker Change: We're actually doing a proper clinical study with a valid results. So that will be done now and that will be published soon so yes, we're making good progress.

Speaker Change: That's great. Thank you very much and have a great day.

Operator: Thank you very much, El-Pezlyan. Have a great night. Thank you. As a reminder, it is star one to join the question.

Speaker Change: Yeah.

Speaker Change: Thank you as a reminder, it is star one to join the question queue. Our next question comes from the line of Steven Ralston with Zacks. Please proceed with your question.

Steven Ralston: Our next question comes from the line of Steven Ralston with Zax. Hey, good morning. Good morning, Steven. Morning.

Steven Ralston: Hey, good morning.

Speaker Change: Good morning, David Good morning.

Steven Ralston: Oh good.

Cameron Reynolds: Oh, first on NuCueVet, what's your operational engagement with your partners like Texas A&M, IDEX, HESCA, Antec? In other words, do you receive any inputs about the potential sales flow? Actually, we have like, I guess, nine or ten different partners now, so everyone's a little different. The bigger ones tend to be not really providing information. It's commercially sensitive for them. We obviously know how many they buy, we obviously know how many they reorder, but they typically quite are reticent about giving the very details. I guess it's commercially sensitive to them. I'd very much like some of it, and so would our team, so we can do a deeper dive on analytics, but as a general rule, the answer is they do not, and that's not a thing for us.

Steven Ralston: First on new cues that.

Speaker Change: What's your operational engagement with your partners like Texas, A&M IDEXX Heska.

Steven Ralston: <unk> and tech.

Steven Ralston: In other words do you receive any inputs about the potential sales flow.

Steven Ralston: Yeah.

Steven Ralston: Actually we are we have like I guess is it nine or 10 different partners now for everyones a little different.

Steven Ralston: The bigger ones tend to be not really provided information it's commercially sensitive for them and we obviously know how many they buy we obviously know how many they reorder but.

Steven Ralston: They typically quite reticent about giving the very detailed.

Steven Ralston: I guess it's.

Steven Ralston: Commercially sensitive.

Steven Ralston: Like some of it.

Steven Ralston: And so what are things that we can do a deeper dive on analytics, but as a general rule the answers they do not and that's not a thing for us its thing for anyone.

Cameron Reynolds: It's a thing for anyone.

Cameron Reynolds: That's just their policies, and as you probably know, even these big companies have quite strict policies for everything, but the short answer is no.

Steven Ralston: Their policies and as you probably noted in these big companies have quite a strict policy for everything.

Steven Ralston: The short answer is no.

Steven Ralston: Thank you.

Steven Ralston: Thank you.

Terig Hughes: Just to follow on to the previous question about the sustainability of the Cost drop. Those two lines, research and development and sales and marketing, they're down 44, 45%. First of all, congratulations on that. But just looking, digging into the weeds at the marketing expenses, you are going to, well, or your partners are going to be attending conferences, that sort of thing. And I assume that's under the marketing budget. Is that going to be a little bit more? difficult to remain flattish for the rest of the year. I do believe that's in the budget, Terig? Yeah, so we have planned for a lower level of spending this year.

Steven Ralston: Just to follow on to the previous question.

Steven Ralston: About the sustainability of the costs drop at those two lines.

Steven Ralston: Research and development and sales and marketing, they're down 44, 45% first of all congratulations on that.

Speaker Change: But just looking digging into the weeds Etsy marketing expenses, you are going too well or your partners are going to be attending conferences that sort of thing and I assume that's under the marketing budget is that going to be a little bit more.

Speaker Change: Difficult to remain flattish for the rest of the year.

Speaker Change: I do believe that sort of in the budgetary yes.

Speaker Change: Yeah. So so we have.

Speaker Change: Planned for a lower level of spending this year. So if you remember last year, we had quite a lot of launches in the year. So spending was naturally higher at that point.

Cameron Reynolds: So if you remember last year, we had quite a lot of launches in the year, so spending was naturally higher at that point. And now it's, to a certain extent, it's sort of baked into business as usual. So yes, we will continue to attend conferences, particularly those where our partners are present. And if we need to, we will spend money, so it may well be lumpy from one quarter to the next. But overall, we've budgeted to spend less money this year versus last year. Yeah, and one thing I would add as well, Steven, in terms of what we're doing to try and save money, is we're attending the conferences to do the networking and meet with the KOL, but we're not necessarily hiring a booth, because that's often what is the costly item at a conference.

Speaker Change: And now it's <unk>.

Speaker Change: To a certain extent, it's sort of baked into business as usual. So yes, we will continue to attend conferences and particularly those.

Speaker Change: Where our partners are present and we.

Speaker Change: If we need to we will spend money. So it may well be lumpy from one quarter to the next but overall and we've budgeted to spend less money this year versus last year.

Speaker Change: One thing I would add as well Stephen and in terms of what we're doing is trying to save money. It's not like we're attending the conference Institute in networking and meet with the K L out, but we're not necessarily hiring appeal because that often is costly item called refinancing.

Cameron Reynolds: And so that definitely helps us manage costs, but we are still active. So for example, Dr. Retter and Dr. Terry Kelly are attending ATS this weekend, the American Thoracic Society, but we don't have a booth at that. So then the costs are limited to just registration and then kind of some of the networking costs. So that's the way that we've kind of clawed back. Yeah, and we still do. Actually, our chief commercialization officer and collaborator is also at the Med Lab conference in Brussels in the next couple of days. But we just do it as cheaply as we can, but effectively, as you can tell by the relationships.

Speaker Change: It's definitely houses and manage costs, but we are still active safety example top to that.

Speaker Change: And Terry Kelly are attending ATF. This weekend, the American thoracic society, but we don't have a deal that they then the costs are limited to just registration and then kind of some of the networking cost say that that's the way that we've kind of claw back yes, we still do I'm actually our chief commercialization officer and collaborators also at the Midland Conference.

Speaker Change: In Brussels in the next couple of days, but we just do it as cheaply as we can.

Speaker Change: Effectively as you can tell by the relationships, but I do think it's very important for our company in this environment, we really get us money.

Cameron Reynolds: But I do think it's very important for a company in this environment. We really get it. It's money, and financing is a premium. So we make sure every dollar is used as wisely as possible. But having said that, we still need to spend money, obviously, to get the product out there, to get the negotiations. We're in front of the biggest companies in the world, so we've got to keep in front of them. But we're very mindful of that. So I believe all the costs we have. And we're actually not sitting on our hands. We are actually continuing to try to cut costs in every way we can while continuing to deliver licensing deals.

Speaker Change: The premium so we make sure every dollar is used as widely as possible, but having said that we still need to spend money, obviously to get the product out there to get the negotiations.

Speaker Change: In front of the biggest companies in the world. So we're going to keep in front of them that we're very mindful of that so I believe all the cost we have.

Speaker Change: Sitting on our hands and we are actually continuing to try to cut costs in every way, we can while continuing to deliver licensing deals.

Speaker Change: Thank you and last question.

Steven Ralston: Thank you.

Steven Ralston: And last question. Thank you for the update on the feline side. Could you do something similar to the progress of that human study contract that you entered into in New Q Discover? A couple of months, I know it's not much time. But when would we see some revenues? Or when would you anticipate some revenues from that in the income statement?

Speaker Change: Thank you for the update on the feline side could you do something similar to the progress of that human study contract that you entered into.

Speaker Change: A new Q discover a couple of months I know, it's not much time, but when would we see some revenues where when would you anticipate some revenues from that.

Speaker Change: Hitting the income statement.

Cameron Reynolds: Sure, so I'll take that one, Steven. So that clinical study is actually will run over up to two years. So it'll be this year and into next year. So the revenue will be spread. So I think that we are taking the first set of sample in the second quarter, but that it will be spread out over a period of time. So it is a longer term clinical study.

Speaker Change: So I'll take that one and say that that clinical study is actually will run as that up to two years.

Speaker Change: You'll see this year and into next year.

Speaker Change: Bethany. These fabs. So I think that we are taking the first half sample in the second quarter.

Speaker Change: In it.

Speaker Change: It will be spread out over a period of time. So it is a longer term clinical study.

Speaker Change: And just to answer I've actually had a few questions about that obviously in the press release, we did not mention the name of the company know that buys.

Cameron Reynolds: And just to answer, I've actually had a few questions about that. Obviously, in the press release, we did not mention the name of the company, nor the size. That's obviously when you sign with big companies, and this is a big company, that's the stipulation. But it was an amount of money that we're very, very happy with, and an organization which is a very large one, and a purpose which is extremely good and down our fairway. So if people read the press releases and wonder why sometimes we don't mention the names, we're very proud of the amounts mentioned, and all the company, and what they're doing.

Speaker Change: Obviously, when you're fine with big companies.

Speaker Change: Big Company, that's the stipulation, but it was an amount of money that we're very very happy with and an organization, which is a very large one had a purpose which is.

Speaker Change: Dreams.

Speaker Change: Good and down our fairway. So if people read the press releases and wanted to buy it sometimes you don't mention the names and we're very proud of the amounts mentioned and all the company and what they're doing but those of you who deal with a large company as noted the first rule is.

Cameron Reynolds: But those of you who deal with large companies know the first rule is you're not allowed to mention any of that in the press release. Certainly not our choice. We're very proud, happy, and it's a landmark contract for us. A Phase 1B2 study, and the amount of revenue was very meaningful, but we just can't in press releases. So I hope people understand the need for that, but it's certainly not from us not wanting to talk about it. We're very excited.

Speaker Change: You mentioned that you've had in the press release, certainly not our choice. We're very proud happy unit landmark contract for us bigger phase <unk> study and the amount of revenue was very meaningful but we just cant in press releases. So I hope people understand the need for that but.

Speaker Change: It's certainly not from us not wanting to talk about it we're very excited.

Speaker Change: Thank you for taking my questions.

Steven Ralston: Thank you for taking my question.

Operator: Thank you Steven, have a great day and a good weekend.

Speaker Change: Thank you Stephen and I have a great day and a good weekend.

Speaker Change: Yeah.

Speaker Change: Thank you, ladies and gentlemen that concludes our time allowed for questions I'll turn the floor back to Mr. Reynolds for final comments.

Operator: Thank you, ladies and gentlemen, that concludes our time allowed for questions.

Cameron Reynolds: I'll turn the floor back to Mr. Reynolds for Thank you, everyone, and thank you for joining the call today. It's obviously a very important time for us. We're now in the commercialisation of all the different things we do. We've obviously just recently strengthened our balance sheet to give us the runway to make sure that we can really deliver on the milestones that we're working on now. It's incredibly exciting this quarter that we had our first revenue from our first licensed human... Sorry, our first regulated human product in the European Union. A very wide range of hospitals now are looking at a very wide range of uses and also all the commercial discussions going on with the large companies on their platforms. So, we're progressing very, very well and the team is really working hard.

Thank you everyone and thank you for joining the call today.

Speaker Change: A very important time for us we're now in the commercialization of all the different things we do.

Speaker Change: Obviously, just recently strengthened our balance sheet to give us the runway to make sure that we can really deliver on the milestones that were working on now.

Speaker Change: Incredibly exciting this quarter that we had our first revenue from our first license cumin.

Speaker Change: Oh good.

Speaker Change: Regulated human product in European Union, a very wide range of hospitals now looking at a very wide range of uses and also all the commercial discussions going on with the large companies on their platforms. So.

Speaker Change: We're progressing very very well and the team is really working hard it's a difficult environment at the moment, obviously in the macro level, but I think we've done a very good job of staying focused cutting costs and really getting the job done. So it should be a very exciting year and thank you all for your interest in the company and we really do appreciate it and I'm looking forward to updating you on the next.

Cameron Reynolds: It's a difficult environment at the moment, obviously, in the macro level, but I think we've done a very good job at staying focused, cutting costs and really getting the job done. So, it should be a very exciting year.

Cameron Reynolds: And I thank you all for your interest in the company. We really do appreciate it. And I'm looking forward to updating you on the next call and we should have made very good progress by then as well. So, thank you again for your time. Thank you.

Speaker Change: Call that we should have made very good progress by that as well. So thank you again for your time.

Speaker Change: Thank you. This concludes today's conference call you may disconnect. Your lines at this time. Thank you for your participation.

Operator: This concludes today's conference call. You may disconnect your lines at this time. Thank you.

Q1 2025 VolitionRx Ltd Earnings Call

Demo

Volition

Earnings

Q1 2025 VolitionRx Ltd Earnings Call

VNRX

Friday, May 16th, 2025 at 12:30 PM

Transcript

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