VolitionRx Limited (VNRX) Q4 2021 Earnings Report, Transcript and Summary

Good morning, ladies and gentlemen. Thank you for standing by. Welcome to VolitionRx Limited's Fourth Quarter and Full Year 2021 Earnings Conference Call. [Operator Instructions] This conference is being recorded today, March 31, 2022. I would now like to turn the conference call over to Scott Powell, Executive Vice President of Investor Relations. Please go ahead.

Thank you, and welcome, everyone, to today's earnings conference call for VolitionRx Limited. This call will cover Volition's financial and operating results for the fourth quarter and full year of 2021, along with a discussion of our recent activities and key upcoming milestones. Following our prepared remarks, we will open the conference call to a question-and-answer session. Also on our call today are Mr. Cameron Reynolds, President and Chief Executive Officer; Mr. Terig Hughes, Chief Financial Officer; and Dr. Tom Butera, Chief Executive Officer of our Volition Veterinary subsidiary. 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. I would now like to turn the call over to our President and Chief Executive Officer, Mr. Cameron Reynolds. Cameron?

Thanks, Scott, and thank you, everyone, for joining Volition's Full Year 2021 Earnings Call today. We especially appreciate your time given the busy earnings call season. We will come to our review of 2021 and financial statements shortly, but given all the activities surrounding Volition Vet, we are delighted to start the call with Dr. Tom Butera, Chief Executive of Volition Veterinary. Then we will do a review of all our other exciting ongoing work. Before I hand over to Tom, I would just like to say that on a personal note that I honestly could not be prouder of the team's achievements in securing a global licensing and supply contract with one of the industry's leading companies, the Heska Corporation. Good deals take time, and this is a very good deal and I could not be happier. And with that, I'll hand over our presentation to Dr. Tom Butera. Tom, over to you.

Thanks very much, Cameron, and hello, everybody. 2021 and this first quarter of 2022 really has been a breakthrough time for Volition Veterinary, and I'm so proud to update all of you on the call today. I fully appreciate everyone will be eager to hear all about our recent announcements regarding the licensing and commercialization of our Nu.Q Vet test. But firstly, I would like to quickly reflect on the team's many other achievements. I first became involved with Volition as an investor. I was attracted to the Nucleosomics platform and thought the technology could be extremely versatile. Fast forward a little while, and I was honored to join Velition's Board of Directors as an independent director in December of 2020. And just a few months later, delighted to join the company full time as Chief Executive Officer of the Volition Veterinary subsidiary. But the hard work started long before I arrived, and so I would like to pay tribute to the whole Volition team who have worked diligently over the last 10 years or more to develop the technology, the product, the branding and the momentum for everything we have today. It's remarkable to me that the memorandum of understanding with Texas A&M University was signed a little under 3 years ago, and our announcement at the time was simply to explore the feasibility of a collaborative research relationship. Wow, we've come a long way in a very short period of time. We went on to establish a subsidiary, finalized our collaboration agreement with Texas A&M, published a paper on pre-analytics, conduct our pivotal clinical studies and beta launch the test in Texas, all within a 2-year period. Some quick footwork for sure. In 2021, Dr. Heather Wilson-Robles published two peer-reviewed papers reporting the detection rates for our Nu.Q Vet Cancer Screening Test in 2 common canine cancers. We believe that this simple, easy-to-use blood test addresses a huge unmet need in the veterinary market. As I have said on previous calls, cancer screening is not yet as commonplace in animal health as it is in human health, but I firmly believe blood tests like the Nu.Q Vet Cancer Test could significantly help transform how veterinarians manage cancer in companion animals. Despite this initial success, our clinical work didn't stop with the screening test. Dr. Wilson-Robles and team have been working on expanding the range of cancers our test detects and also on expanding the potential use of Nu.Q Vet for the monitoring of diseases. In the fourth quarter of 2021, I was excited that the first data in relation using the Nu.Q Vet test as a monitoring tool was published. Not to get too technical here, but the data presented at the Veterinary Cancer Society Conference in late 2021 demonstrates that Nu.Q Vet may serve as a more sensitive measurement of both minimal residual disease and remission and could be very useful monitoring tests for dogs with cancer. We believe that being able to use the Nu.Q Vet test to not only screen for cancer, as per our current product, helping identify disease earlier, but also then to be able to help monitor the disease progression as an early indication that a dog is coming out of remission will meet a real unmet need in the market. The first data regarding the Nu.Q Vet test monitoring capabilities was really terrific. And I know that Dr. Wilson Robles and the whole team are excited to finish the study of over 100 dogs early in 2022, submit the study again for peer-reviewed publication and then progress on to an expected launch later this year. The clinical team has also completed the analysis of over 600 canine subjects, 504 cancer patients and 135 healthy control dogs. Unfortunately, I cannot say too much on the call today as this data has been accepted for publication at a widely read veterinary journal and is currently under review. But I am happy to say that nucleosome levels were evaluated in plasma samples from patients with 7 of the most common canine cancers, so we expect to broaden our marketing claims in the coming months. So please watch this space for further data updates on this multi-cancer topic. These studies, papers and conference publications, while time-consuming, are helping to build our profile and credibility with KOLs, oncology specialists, GP doctors, and importantly, our current and potential licensing partners. I firmly believe this will position us in a leadership position within the veterinary oncology space long term. And so speaking of licensee partners, I honestly could not be prouder of our achievement as incurring global licensing and supply contract with one of the industry's leading companies, Heska Corporation. Heska is a leading global provider of advanced veterinary diagnostic and specialty products and is dedicated to developing the next generation of rapid, low-cost, point-of-care diagnostics for companion animals. It has a worldwide distribution and partnering network. Heska very much shares our philosophy, our work ethic and vision as to how Nu.Q Vet can really help save lives and improve outcomes for millions of pets worldwide. Our executive agreement with Heska provides: exclusive rights to sell Volition Nu.Q Vet Cancer Test for companion animals at the point of care, nonexclusive rights to sell the Nu.Q Vet cancer test for companion animals via Heska's reference laboratories and exclusive rights to canine cancer monitoring and feline lymphoma tests as well as certain rights to potentially commercialize a wider test menu for companion animals, again, at the point of care. This multiyear global supply and license agreement totals up to $28 million in milestone payments in addition to ongoing payment for kits and kit components. The exclusive part of this agreement is providing the Nu.Q Vet test at the Point of Care for companion animals. The plan is to transfer the Nu.Q Vet Cancer Test on to Heska's Point of Care platform, the Element i+ Immunodiagnostic Analyzer. As background, Heska's Element i+ Immunodiagnostics Analyzer is a point-of-care platform, providing veterinarians with rapid, accurate low-cost and easy-to-use testing which support their clinical decision, making in real time at the point of care in the doctor's office. In the future, veterinarians in both hospital and clinical settings will be able to detect cancer early and monitor treatment response by testing within their very own practice. Both Volition and Heska firmly believe this will help improve outcomes for both pets and pet owners. The agreement also provides a nonexclusive license to Heska for the provision of the Nu.Q Vet test for companion animals through the reference lab route. Whilst Volition and Heska are starting with canine cancer detection, our focus is also likely to include disease monitoring in the near term and other companion animals, such as felines in the midterm. Given the party's belief that the market potential and likely breadth of the use of the new QVE technology is significant, the negotiation and due diligence process has been extensive, and therefore, time consuming. And so we thank you for your patience in awaiting this news. But we are absolutely delighted. It has been fantastic getting to know the Heska team, and we very much look forward to a long and fruitful relationship. And secondly, as a reminder, as it seems some time ago now, but in December 2021, we also appointed SAGE Healthcare to serve as a nonexclusive licensee and distributor for Volition new CVT cancer screening Test in centralized labs in Singapore, followed by expansion in conjunction with SAGE Healthcare into centralized labs and other key Asian markets. Launch preparations at SAGE are well underway, and I look forward to providing updates on future earnings calls. We remain in advanced negotiations with other potential licensing partners in our efforts to make Nu.Q Vet as accessible as possible worldwide, and so please watch this space for further details in 2022. All in all, an incredibly busy time for the whole Volition veterinary team and many of the Volition executives, too. I would like to publicly commend and sincerely thank the team for their hard work in a great job well done. And I truly think all of our efforts will be worth it. In the near term, for canine cancer, some statistics that demonstrate the opportunity, 1 in 4 dogs will develop cancer, almost 50% of dogs over the age of 10 will develop cancer, 6 million new cancer diagnoses are made in dogs each year in the United States alone and 470 million dogs live as pets worldwide and the number continues to increase year-on-year. To help us access these opportunities, I am delighted to say that in the first quarter of 2022, we have added significant strength to the Volition Veterinary subsidiary with the appointment of a product manager to help drive our product development program, a marketing manager to continue to build the awareness and credibility of Nu.Q Vet and a global account manager to work with our partners and key accounts to drive the business. Welcome to the team, Daniel, Devon and Christi. And so to the future and what's coming up next. Negotiations continue for other potential licensing opportunities in our efforts to make the Nu.Q Vet as accessible as possible worldwide, and we expect to announce further developments along those lines in 2022. I am also delighted to say that for all the cat lovers out there that we have started collection for our feline cancer study. Feline samples are notoriously more challenging to collect, but the study is now underway, and we look forward to reporting study results in due course. We continue to have a busy conference schedule, having already attended and presented at both VMX and WVC in 2022, and with some important upcoming events in Europe as we start to spread our wings and build awareness in other countries with conference attendance planned in Italy, Germany, France, and the U.K. I'd like to thank you for your attention and indeed, for your interest in Volition Veterinary. With our published data and now the execution of our licensing and supply agreement with Heska, along with our supply and license agreement with SAGE Healthcare, we are really gaining momentum. I, along with the whole team, and indeed our partners, believe that our Nu.Q Vet test meets a significant unmet need in the market and could eventually be one of the most popular diagnostic tests utilized by the veterinary community in the future. And with that, I'll pass it back to Cameron.

Thanks, Tom, for that very comprehensive update and thanks to the Vet team and indeed the whole Volition team for their hard work in reaching this fantastic milestone. I am delighted with the progress we have made in this key area as we progress strongly from purely a research and development company to one with a wide range of products. It is an exciting, fast-moving part of our business with clear potential to generate significant revenue for the company in terms of both milestone payments and an ongoing revenue stream from the sales of kits and key components to Heska and SAGE Healthcare, both at a very healthy margin. And now on to other aspects of our business review, starting with what I believe is the most important element, our people. Throughout 2021, and indeed into the first quarter of 2022, we've expanded our team and strengthened the bench with some incredibly talented recruits. To support our commercial expansion, we welcome Terig Hughes as our Chief Financial Officer; Gael Forterre as our Chief Commercialization Officer; and Dr. Tom Butera as the Chief Executive of our Vet subsidiary. In addition, we also hired our Chief General Counsel, Nick; and moved Gaetan Michel to head up our U.S. operations as our Chief Operating Officer, to accelerate development of Volition America. The caliber, experience and expertise that Nick, Terig, Gail, Tom and Gaetan collectively bring to Volition’s leadership team, put the company in a strong position and certainly their skill set was showcased during the recently announced Heska agreement. Meanwhile, Dr. Terry Kelly was promoted to Chief Innovation Officer and works from our California lab. Terry is doing an excellent job of building a team focused on cutting-edge discovery research at our new innovation hub, which opens in California this month, to help drive work in our cutting-edge Capture program and other exciting areas. And as you heard earlier from Tom, our expansion has continued into the first quarter with new appointments to the Vet team. People are at the heart of everything we do. I'd like to welcome our newest colleagues and congratulate our team members on their promotions. And I'd like to thank the entire team for all their efforts and many achievements in 2021. Our next key element of the company is our patents. As of year-end 2021, our patent portfolio included 29 patent families and a total of 84 patents granted related to our diagnostic tests, including veterinary applications, with 12 patents granted in the U.S., 14 in Europe and a further 58 worldwide. Additionally, we have a total of 93 other patent applications currently pending worldwide. Our next key element of the company is our products. We have 5 product pillars, one of which Tom covered earlier with regards to Nu.Q Vet. Our next pillar is Nu.Q NETs. During 2021, we put significant efforts towards developing a new product, Nu.Q NETs to detect NETosis. Data published at conferences thus far show that the level of circulating NETs as measured using our Nu.Q NETs assays, correlates with current disease severity and mortality in COVID-19 patients. In addition, the study showed that our NETs-based tests could be used to predict future disease severity and guide treatment selection in patients on admission. We intend to register our Nu.Q NETs product with a broad almost CRP-style claim for the detection and evaluation of infection, tissue injury, inflammatory disorders and disease associated with NETosis. We believe that not only is this broad claim achievable, it also gives us the largest possible market opportunity. Further, we have established proof of concept for Nu.Q NETs as an effective test to monitor response to a novel treatment for sepsis. The development of NETs once again underlines the breadth of the Nu.Q platform technology, which is supported by our robust intellectual property portfolio. We have a product manager in place and are driving forward our plans for commercialization, aiming to CE Mark, Nu.Q NETs across multiple platforms this summer. We're also developing a U.S. clinical study plan geared towards FDA approval of our Nu.Q NETs product, which we expect to start a pilot study later this year. Next up, Nu.Q Discover, and I'm delighted to report some very strong progress in the commercialization of this product pillar in recent months. As a reminder, Nu.Q Discover gives clinicians, patients and researchers access to a range of state-of-the-art assays built on our proprietary nucleosomic platform for rapid epigenetic profiling in disease model development, preclinical testing and clinical trials. Our H3.1 assay is also available for purchase as a research kit. Our assays running at our Silver One facility in Belgium or on site can be used to answer clinical questions such as measuring treatment efficacy or on-target and off-target effects in drug development. Applications include biomarker discovery oncology, inflammatory conditions, diabetes and more. Existing and potential customers include both pharmaceutical companies and academic research institutions. I am very happy to announce today that we hit our milestone of signing our first Nu.Q Discover agreement in 2021. We've enjoyed excellent momentum so far in 2022, having signed a further 5 additional agreements worth an aggregate of a little over $200,000 on a full year basis. This has been a great few months with 6 deals in total being signed. Interestingly, the agreements involve 5 separate organizations and our real mix of pharma and academic research customers from a wide range of disciplines. We believe that this really demonstrates the amazing adaptability of our Nu.Q platform beyond our core work. We currently estimate the total addressable market for Nu.Q Discover to be over $200 million per annum worldwide, but it's a tough area to get good visibility on revenues going forward due to the wide range of studies we aim to be working with. The opportunity is calculated using publicly available drug pipeline data, the number of clinical trials and the average failure rates for relevant epigenetic targets. On average, we estimate revenues are in the region of $40,000 for the preclinical phase, $150,000 for Phase 1, $200,000 for Phase 2 and over $750,000 for Phase II. And clearly, if the drug is subsequently registered and commercialized, then larger additional ongoing revenue would be expected. Now these are quite large numbers but they would only be expected over quite a significant period. For example, it takes an average of 10 years to go from preclinical phase to commercialization. Also, these numbers, including our estimated total addressable market are, of course, subject to fluctuations based on numerous assumptions, which, if prove incorrect, could materially impact our estimations and results. So fairly significant, its somewhat unpredictable revenue stream, but we are delighted to get up and running with our first wide-ranging contracts. And talking of revenue, I will now pass over to our Chief Financial Officer, Terig Hughes, to provide a summary of the financial report of our full fiscal year 2021 in addition to updating you on other financial-related projects. Terry will also provide an overview of what we estimate our total addressable markets to be across our multiple product pillars. Terig, over to you.

Thanks, Cameron, and thank you, everyone, for joining our earnings call today. I'll now provide a summary of the key financial results for the year ended 31st of December 2021. We closed out the year with cash and cash equivalents of approximately $20.6 million compared with $19.4 million at the end of 2020. I'll just take a moment to recap our financing activities for the year. You may recall that back in January 2021, we announced the award of approximately $4 million in nondilutive funding from the Walloon region and the more invest in Belgium. That funding supported the purchase and fit-out of Silver One, our new production facility in Belgium, as well as a number of ongoing cutting-edge research and development projects. That was followed in February by an underwritten public offering of our common stock, which raised net proceeds of approximately $18.9 million. Last but not least, through the course of the year, we also received net receipts of approximately $4.6 million from equity sales through our at-the-market equity distribution programs. We continue to manage our expenditure carefully. And whilst there is some quarterly variation and indeed, the overall level of expenditure has increased in 2021 as compared to prior periods, we have an underlying cash burn of approximately $2 million per month. We expect that may increase slightly in the first quarter of 2022 as it did in the first quarter of 2021. Moving on to the P&L, the net loss for the full fiscal year 2021 was $27 million versus $20.4 million loss for the prior year. Research and development spending was $15.5 million in 2021, an increase of approximately $1 million as compared to 2020, and was primarily impacted by higher personnel costs due to new hires. General and administrative expenses were $8.8 million in 2021, an increase of approximately $3.1 million as compared to 2020, and were primarily driven by higher noncash-based compensation costs, which partly reflected one-off charges to extend option expiration periods from 6 to 10 years to align with market norms. Sales and marketing costs were $4.1 million in 2021, an increase of approximately $3.1 million as compared to 2020, and were primarily impacted by higher personnel costs as we build out our commercial team. Grant income recorded in 2021 was $1.5 million compared with $0.6 million in 2020. From a revenue perspective, we recorded $90,000 in 2021, the majority of which was from sales of the Nu.Q Vet test related to our beta launch with a single lab at Texas A&M University, and the remainder from initial sales of Nu.Q Discover to customers in Europe. So to recap, we closed the year out with a strong balance sheet with cash and cash equivalents of approximately $20.6 million. Subsequent to year-end and as discussed by both Cameron and Tom, we are delighted to have executed a licensing and supply agreement with Heska Corporation for the Nu.Q Vet Cancer Test. To reiterate, under the Heska agreement, Volition will receive an upfront payment of $10 million, up to $18 million based upon the achievement of near and midterm milestones and payment for kits and key components at pre-agreed prices, which we expect will provide a significant future revenue stream with margins that reflect the value of our intellectual property. This is fantastic news for the company. And like Cameron and Tom, I'd like to offer my congratulations to the whole team. It is great to feel we are now up and running on our commercial journey. In terms of our revenue outlook, it's hard to predict with any certainty the ramp-up in product sales this year. So erring on the side of caution, we would say, including the upfront payment from the Heska deal, we would expect full year revenues to be around $10.5 million, with expectations of a significant ramp-up in product sales from the start of 2023 onwards. And so here might be a good point to provide a summary of our markets and their size. We estimate our total annual addressable market, or TAM, to be approximately $70 billion worldwide, including Nu.Q Vet, Nu.Q Discover, Nu.Q NETs and Nu.Q Cancer. This estimate of our annual TAM is broken down with key assumptions as follows. We estimate the Nu.Q VET TAM to be approximately $11 billion annually worldwide based on global canine and feline populations that are eligible for screening and monitoring at a price assumption of $50 per test to the consumer. For Nu.Q Discover, we estimate our opportunity to be over $200 million per annum on a worldwide basis. We estimate this using drug pipeline data of registered clinical trial programs for relevant epigenetic targets. Moving to our future product launches, we estimate the Nu.Q NETs TAM to be approximately $22 billion annually on a worldwide basis. Unfortunately, sepsis remains all too prevalent, accounting for approximately 20% of deaths worldwide. Our TAM was calculated based on estimated hospital admissions and discharges for sepsis and the associated average length of stay. And last but not least, we estimate our Nu.Q Cancer TAM to be approximately $37 billion annually on a worldwide basis. This was calculated based on eligible populations for annual screening, target participation rates and incidence and prevalence of specific cancers and risk stratification use cases. Price per test assumptions for Nu.Q and Nu.Q NETs range from $120 for the U.S. to $50 for Europe and $25 for the rest of the world. Given the product range, we believe we can develop from our proprietary Nucleosomics platform, we believe our addressable markets are significant, and we look forward to accessing those opportunities and reporting in due course. Please note, however, that these numbers, including our estimated total addressable markets, are of course subject to fluctuations based on numerous assumptions, which, if proved incorrect, could materially impact our estimations and results. We have made strong progress on many fronts in 2021 laying the foundations for our commercialization journey, where we have already seen our first success in the first quarter of 2022. And with that, I will hand back to Cameron for his update on the future product pipeline and upcoming milestones. Cameron?

Thanks very much, Terig, for that comprehensive financial report and for highlighting the tremendous commercial opportunity we have before us. I appreciate given all the news, this is quite a long call. But before we wrap up, I'd like to provide a quick update on another one of our pillars, our Nu.Q Cancer program. Overall, the impact of the pandemic on our business has been most notably limited to delaying collections of studies and supply issues. For example, our U.S. studies have encountered delays. With the NHL study, we took the opportunity to alter the study protocol to upgrade the platform to a high throughput platform from plates, which will help us facilitate an FDA-compliant product and are shifting away from frozen to fresh samples. We currently anticipate the U.S. NHL study collection will begin in the second quarter of this year, and I'll be sure to keep you abreast of developments as we move through the year. The U.S. colorectal cancer study led by EDRN, the Early Detection Research Network, reinitiated enrollment in June of 2021 and has continued to enroll subjects during the pandemic at a steady, but unfortunately decreased rate. As government health care agencies begin to relax pandemic restrictions, the actual rate is expected to increase accordingly. The EDRN still estimates the study completion date to be at the end of 2022. The brightest note in this product pillar during the pandemic is Asia, where we not only reached our target patient cohorts for both colorectal cancer studies and the lung cancer study, all collected in conjunction with the National Taiwan University, but have also presented initial data from the colorectal cancer study at the prestigious ASCO GI meeting held earlier this year. It is great to have this first data out, and we look forward to sharing more analysis in the future. The lung team has also completed their preliminary analysis and submitted abstracts for the lung cancer study for 2 conferences to be held later this year. So please watch this space for that. And so to our last product pillar, Nu.Q Capture. As I have said on previous calls, we believe the Nu.Q Capture technology will be transformational as a DNA enrichment technology, which could potentially aid diagnosis, treatment selection and both treatment and disease monitoring when used in combination with either sequencing, mass spectrometry and/or our Nu.Q assays. The Nu.Q Capture program now has several other strands of technology which either essentially removes background noise, thereby amplifying the signal, or looks to identify the signal in a novel way. Further strands of the Nu.Q Capture technology involves isolating various chromatin fragrances, including nucosomes and transcription factors from plasma from analysis by mass spectrometry and next-generation DNA sequencing. So together, we are currently actively working on 4 different strands for Nu.Q Capture in Belgium and in our new California lab, all of which are potentially very exciting product areas. In 2021, a novel method utilizing Nu.Q Capture and mass spec was published and demonstrates the detection and quantification of histone modifications present in the circulating nucleosomes in the blood of cancer patients. Furthermore, the use of our Nu.Q Capture technology may open up the possibility of using mass spec not only for biomarker discovery, as demonstrated in this paper, but also as a high throughput platform for screening and/or diagnostics when used in combination with either segmenting or our Nu.Q assays. This has progressed to the stage whereby we are now working on setting up a large 1,000-plus patient study in lung cancer and colorectal cancer, and I look forward to updating you this later this year. It is incredibly exciting potentially IP-rich breakthrough technology, and we expect to report and publish further findings throughout 2022 and beyond. And so in conclusion, I am delighted with the significant progress we made on many of our product pillars in 2021, in particular in continuing to strengthen both our intellectual property portfolio and our exceptional team. I am, of course, incredibly proud of the team's achievements in securing a global licensing and supply contract with one of the industry's leading companies, the Heska Corporation, a great job well done. Heska and SAGE very much share our philosophy, our work ethic and vision as to how Nu.Q Vet can really help save lives and improve outcomes for millions of pets worldwide, and we're excited to move forward to the next phase. As Tom said, negotiations continue for other potential licensing and opportunities in our efforts to make Nu.Q Vet as accessible as possible worldwide and we expect to announce further developments along those lines this year. I, along with the rest of the Board and indeed the whole company, very much look forward to sharing further news regarding Volition Vet and our other subsidiaries, as well as the results of our key clinical studies, publications and milestones over the coming months and quarters. Thanks so much for joining the call today. We very much appreciate it, given the earnings call season. We're happy to take questions now. Operator?

[Operator Instructions] Our first question comes from the line of Ross Osborn with Cantor Fitzgerald.

Congrats on all the progress. So starting off, I know you're not giving quarterly guidance, but could you help us think about how the year should progress toward the $10.5 million you guided? Any clarity there would be helpful.

Yes. Terig, do you want to take that?

Yes, sure. So as Cameron mentioned earlier, the Nu.Q Discover revenue can be somewhat unpredictable. But we do have a number of contracts already signed. So that will form part of the revenue that we see through the balance of the year. And as we said, we've taken a fairly conservative approach in terms of the ramp-up of the product sales and the vet product, expecting the commercial launch to be sort of somewhere towards the end of the year or beginning of next year. And therefore, we would expect that to ramp up much more significantly next year. So I think what you'll see is a stream of sort of growing quarterly revenues from the other products, and then perhaps the -- some small amounts of revenue coming in from the Vet products towards the end of the year. Sorry, I can't give a more clear answer on the quarter-by-quarter at this point, but it's just a little bit unpredictable.

Yes. And I think just to talk about, just in general as well, I think it did surprise us. I think all the models were what we thought, which was kind of a slow year for any revenue. So getting this upfront payment, which goes straight to the bottom line of $10 million. It's already arrived in our accounts. So I think we're already 110x last year's revenue with 1 check. So that's [110x] gain, so that's a good start for the year. There may be some other milestone payments late this year or from the -- there's 3 more milestone payments, a total of 18, coming in from Heska if those milestones are achieved. And I think they're all quite achievable, either this year or next. And as you can see, the Nu.Q Discover’s certainly picked up a lot, six deals is absolutely fantastic. The dam kind of burst, we sorted out the IP issues and we had to make sure we had all the quality we needed for all the things we're doing, and now we have sorted out the contractual issues. That was a fantastic outcome to go from 1 to now 6 in a few months, which together is also more than double last year’s revenue or 2 or 3x last year's revenue. The sales, we're not quite sure, as Terig said, because it depends on the ramp up and that's now in the hands of several external companies. But SAGE's launch is coming in a few weeks, so they'll start selling the vets in Singapore. Texas A&M is still selling the test, of course and then this contract. And we're also hoping to sign some of the large reference labs contracts sometime soon. So that's possibly going to come in this year as well. But we don't really know until that’s all have been done. So we're being conservative, but I think that conservative figure is far, far bigger than anyone was expecting for the entire year. But given the nature of it all, it can be lumpy with the Discover and milestone payments. So it's a little hard to predict, but we just could not be happier that we're in March now and we're already at 110x in 1 check what we got last year. So it's a great start, but we'll guide as we -- as it becomes more obvious to us what the revenue is. But the aim is to get the big payments in and also increase the incremental revenue solidly quarter-on-quarter as it ramps up.

Okay. Great. It sounds like you're off to a great start. So maybe one more for me and then I'll jump back in the queue. Just given the lockdowns in China, has that adjusted your Asia commercialization plans involving SAGE? And then what countries will you initially target towards the beta launch in Singapore?

Yes. So it's certainly affected China. We've been working with a large company there. They've been fantastic. But obviously, they're a little -- it's quite focused on COVID still. Whereas Singapore is coming out of it, the launch is in a few weeks' time, so keep an eye out for that. And SAGE is more focused in the short term on Southeast Asia, and they are quite rapidly lifting their lockdowns now as well. So I think it definitely has affected the Chinese market. And -- but the Southeast Asia, where I think SAGE will be focusing in the short term is really starting to move now. And sorry, Ross, what was the second part of that question?

No, you addressed it. Congrats again.

Thanks for your questions. Have a great day.

Our next question comes from the line of Bruce Jackson with The Benchmark Company.

Just a few more Vet questions. You've discussed maybe giving some more contracts in the lab space. Heska does have a bit of a footprint in Europe. Are you going after any of the other labs in Europe? .

Yes. So yes, so I guess the whole background, and then I guess, Tom can answer from the European side. But I mean, it's been -- as Tom said, it's a fantastic outcome from Heska. But they are focused on Point of Care. They do have some reference labs, and I believe they're intending to launch in those. We do have very active negotiations with the big vet companies, and they've gone well. So that could be news in the short term. But as with SAGE, a part of the asset could well be regional players throughout the world, and we're in discussions with a few of those beyond the big players. So -- and I think to really get to our vision of being in as many labs as possible in front of many vet owners as possible worldwide, to reach as many of those 0.5 billion dogs as there are in the world, we should be in as many deals as we can. So there'll be some more news on that later this year. Tom, do you want to speak to this?

Yes. I just was going to add to that, that the -- we have a significant European strategy currently underway. We've had tremendous interest from the European reference labs as well. And we anticipate that there will be agreements signed with them as well during the course of 2022 and going into 2023.

Okay. Great. And then in terms of the feline testing. So collecting samples right now, realistically, when could that test beyond the market and have some impact on revenue? Is this more of a 2024 type of product? Or could it contribute to 2023?

Tom?

Yes. I think realistically, we're going to be doing a lot of the collection in 2022, the latter part of 2022. The initial validation tests and the initial validation work will be done in 2022. So anticipation would be, at least our goal, was to, in 2023, try to bring that test to market.

Okay.

Which would probably mean 2024 revenue as sort of a year behind. I think this year is about signing the deals and getting it available and launching some good revenues, but I think it will really ramp up next year. So I guess that will be -- on the dog side. So I guess that would be more a '24 story for the cat market. Yes, apart from upfront payments and things like we have in the dog market, but the actual product revenue would be for 2024. It's exciting. It's really coming together very well.

Yes, absolutely. Moving over to the EDRN study in the United States. When they say they're going to finish, that means -- does that mean the collection of samples and then you do the testing? Or is the testing ongoing right now? So in terms of the time line, maybe ’24 --

No, no. It started, yes. So that's a '23, '24 story. Yes, that's the one thing. I think what we've done now has been a tremendous validation and indication of our strategy in the vet space and the focus to really push that now. The human cancer space in the U.S. has been slower because of the pandemic. Understandably, people don't want to go part of a trial when the hospital was a closed or the fear out there. So that has slowed. But I think as you can see, we've used our time very wisely. So I think that will be a '23, '24 story for the EDRN side.

Okay. Got it. And then last question from me. On the burn, you've been running at maybe about $2 million a month. Is that going to tick up slightly this year with the extra hires and everything? Or should we still be modeling that roughly $2 million per month burn rate.

Terig?

Yes. I think, yes, it's -- so currently running on average 2 in a month. The first quarter will be a bit higher as it always is. And throughout the year, we can expect it to tick up a little bit as activities ramp up.

All right. Great. And congratulations on all the progress.

Thank you. Thank you for your time, Bruce.

Our next question comes from the line of Nathan Weinstein with Aegis Capital.

Firstly, congratulations on securing this licensing deal with Heska, very well-established and highly respected diagnostics company. So I was really excited to see that press release come across. And I guess I'll just start with the question on the Nu.Q Vet side. Just prior to revenues ramping there from product sales, like how do we track sort of the progress of the partnership over the next year? So will that be around milestone announcements? Or how do we keep an eye on that?

I think we'll update as a corporation on the quarterly calls. But we are hitting the ground running. They had the kickoff meeting call yesterday. So Heska is really keen to get it out there quickly. We've spent a lot of time working with them, adapting to the Element i+ platform and they're looking also to launch as a lateral flow test, like a snap test. So that's in constant development. And they also, of course, had the rights to launch it in their laboratories as well in their reference labs. So I think there will be lots of things going on. They're very serious about hitting it running. I think showing $28 million in payments, including 10 on signing, shows that I think it's a very big product. And as you said, I think it's a great deal for everyone. It's exactly the deal I like. It's good for us. It's good for Heska. It's good for dogs, potentially cats. And it's good for everyone because it's a real need in the market. And I think they're a very dynamic company. They're really looking to dominate the point-of-care space. And I think they've made a very good decision in working with us to launch this test at the point of care. So we'll update our big events on the earnings calls and updates as it goes through the year. And also, of course, there are 3 milestone payments totaling $18 million to come, which we think are very achievable this year and next. So that will be the big ones, I guess. And as the revenue comes in from then -- and as I said, SAGE is also launching this month -- sorry, in April, in a few weeks' time. So there will be a steady drumbeat of different things happening.

Okay. Fair enough. And then just turning to Nu.Q Discover. Obviously, signing several agreements. There worth a couple of hundred thousand dollars, that number is starting to get interesting. I guess, can you sort of break out how those dollar figures go up as you have a customer that's further along in clinical trials? Is it because they're ordering more product or different products later in their trial -- in the trials?

Typically, it's the same. It depends on -- so it's about half universities and half pharma companies. So as you – at first, they order a few kits and that works, they order a few more. So sometimes they go from 5,000 or 10,000 to 40,000. And then it can jump to the hundreds of thousands to be part of the next stage. And then if it becomes part of the product in the companion or very key in the drug development or the research program, it can be worth a lot of money. So it's been interesting. We've really learned a lot about our assays and what the whole industry. It's serving a few purposes. It's a nice source of early revenue. A few hundred thousand dollars from this alone sort of more than doubles our revenue from last year from everything. So it's interesting just for incremental revenue growth. It also shows the versatility of the platform. But I think also, it really allows us to kind of understand what's going on in epigenetics. We have big aims to be at the heart of epigenetics and provide a lot of tools for a lot of people. So working with different groups in different areas really allows us to be at the heart of what's going on in this incredibly exciting space. So it is the revenue, and that's been very nice, but it's also really keeping track of a lot of different things so we can better understand epigenetics ourselves and our own products, and also really help them through this process.

Okay. Fantastic. And then just one final question from me -- I'm sorry to jump around, but there's a lot of different projects you're working on. So I really do want to ask about Nu.Q NETs, if you don't mind. And you did discuss Nu.Q NETs at length, but maybe just remind us or summarize what are the next prospective catalysts in that program.

Yes. Actually, that's really been growing extremely strongly below the surface. We've hired team members to really drive it. So NETosis, which just to remind everyone, is what kills the majority of people in COVID; but also sepsis, which is one of the biggest killers, if not the biggest killers in hospitals. And it's very hard to detect particularly early, quickly, cheaply easily, what we do. So we're incredibly excited about this product platform. It's exactly the same platform we've been using. And so we're expecting our first CE Marks quite soon. The regulations are changing in Europe in a few months' time. So we're trying to get some of them before the regulations change. So in this sort of summer time frame, we'd expect a few CE Marks on different platforms. Why different platforms, for different purposes. Sometimes you want to run in a lab or a lab machine. Sometimes you want to at the point of care. Sometimes you want plates. And if we are going to get to something like CRP, which is 85 million tests a year, this information marker, which NETosis is, of course, partly from information, we need to go on different platforms. So the next sort of wave of news will be the CE Marks for the European launches -- I'm sorry, the development of the products and then launches. And the U.S., part of what I was doing in the U.S. this last trip when I was in the States, was really work sitting down on the U.S. regulatory side. So expect to see some key hires in the U.S. on the regulatory side in the short term. I think some quite exciting people are going to be joining us to really help us drive the U.S. regulatory side. And we think beyond the cancer processes we're in now, the really exciting one is in Nu.Q NETs, particularly aiming at sepsis, which is also a tragic killer. So expect to see a lot of information on how we intend to launch in the U.S. our NETosis products, which we expect to be fantastic blockbuster later this year. And so over the summer, the CE Mark in Europe, and later this year, the U.S. strategy and a lot more data and a lot more information coming out. And we're also working with companies to be a companion diagnostic. Obviously, diagnosing is 1 thing, helping to treat NETs is another, so expect to see some information on that this year as well. So yes, there is a lot going on, and we can do it because we have a very versatile, adaptable, very simple platform that can be used in many areas, and Nu.Q NETs will be a very big part of that in the second half -- over the summer in the second half of this year, we think.

Okay. Great. Congrats to you, Dr. Butera and the whole team at Volition, on all the progress, especially on the Vet side.

Our next question comes from Michael Okunewitch with Maxim. Please proceed with your question.

So I wanted to ask regarding the Heska point-of-care diagnostics platform, how wide reaching is that as it stands? And is there a base platform widely available at vet labs and clinic?

Tom, do you want to answer that?

Yes. The -- it's Michael? Michael, the Heska is the #1 -- their entire focus is point-of-care diagnostics. That's where they have there. strongest emphasis, and that's where they have their biggest footprint. Just to kind of give you an idea on a U.S. basis alone, pretty close to 70% of the veterinary hospitals that are out there had in-house laboratories, and Heska probably has at least 15% of that market. And with the introduction eventually of our Point of Care test with them and especially with reference to cancer, it's going to be something that veterinarians are going to very much gravitate to. So the anticipation is that, especially with reference there, their Elementi immuno Analyze that we spoke about, it's going to be probably a significant uptick for them in terms of use in the in-house lab market.

Michael, don't also forget it's not just the machine. This is a point-of-care license. So I believe that they are serious developing lateral flow tests as well, which do not need a machine and can be run anywhere as well. So I think they're all about the entire point-of-care solution. So the machines are obviously a big part of it, and the machine they use is fantastic. A very accurate, very reliable platform. But they're also, I think, looking to move into more disposable test as well. So that's really a viable worldwide through the machines and also through lab tests or lateral flow.

All right. I appreciate the extra color. I'd just like to see also if you could provide a bit more granularity on the economics behind sales through Heska in the point-of-care setting, as well as the milestone, what those are for? Are those largely development milestones, sales milestones. Could you talk a bit about that?

Yes. So obviously, we've got to be a little careful. We're negotiating with 2 other companies at the moment. So we don't want to give too much away of it all. First of all, we're very happy. I think it's a good deal for us and for them for all the reasons we talked about. So the milestone payments are fantastic. There's $18 million more coming in milestone payments, if we achieve those milestones. And I think there's a reason -- a good chance we could do them, all the 3 of them, by the end of next year. And they pertain to the product launches and also to the feline milestone, as we discussed. And as far as what we've said -- obviously, we've got to be careful for the reasons we talked about. But we're very happy with deal we have. For the kits, we're looking at about $10 coming to us. And if the price is sort of $50 to the end user, Heska would expect to get about half of that and we would get what we said from us. And if we're selling components, it's cheaper than the kit because obviously, we don't have to put together a kit, so it's less than $10 for us, but $10 per kit and reduced for the components. So that's, I think, a very healthy percentage for us, and it really shows our strategy of Silver One and producing the key components, allow us to provide a big part of the solution to the vet companies, so they don't have to do any development work. They don't need to produce anything themselves. We sale the antibodies in the controls, which are very, very good ones we produce now. I think we produce the best in the world, certainly the nucleosomes, the recombinant nucleosomes, and so Heska can adapt to their machines or to the other point-of-care platforms or lateral flows. So we get the milestone payments. And then I think a very reasonable percentage of the revenue because we provide not only the IP, we also provide fantastic key components, which means they don't have to develop them. Is that how you said, Tom?

Yes, it is, Cameron.

Yes. I also wanted to touch on the NETosis program. Because you mentioned you're going for a broad CRP-style claim and that you're potentially getting a CE Mark over the summer. So after you secure that claim, what would be the next steps for Nu.Q NET to drive its adoption as a clinical product?

Very good question. So we're now in the process. As I said, we've taken on a NETosis product life cycle manager, and it's his job to put together the team to launch the product in Europe and we're working on the U.S. strategy. So the CE Mark means you can sell it for that purpose. And if you want a clinical adoption, you have a wide range of proof that works very well. So we're working with some great key opinion leaders, some great world-renowned hospitals and universities, showing how useful it is in the clinical setting. So the clinical products will be used in publications, in trials, and showing a really strong background and how well it works. Also, clinical adoption is partly driven by being on a lot of different platforms. As I said, some people want a centralize lab. If you're not in a hurry, taking 4 or 5 hours in the lab is fine. If you've got someone in emergency or intensive care, you want something pretty quick, that's when you go for a point of care. And this is where the whole business lives off each other and helps each other. The Point of Care platform for the vet space can also help us in the human space and vice versa. So to get adoption, we're getting the regulatory approval, then we're getting a lot of great key opinion leaders behind the product and showing how well it works, and that they back it and we'll use it. And then we make it available on as many platforms as possible, so that it's easily at hand, if you will, to whoever is looking for the test to be run. And as I said, it's something which we think is incredibly useful. And the total addressable market looks at people have been giving it every day when they're in emergency, which I think is very valid function given how deadly sepsis is and knowing it's starting to get sepsis or how bad it is, is incredibly important. And I think even everyone that goes into hospital on the first and last day knowing if NETosis is becoming a problem because it is such a massive killer. So I think we're working through the strategies now and we'll update on the coming quarters. But I think we've got a very good indication now of the path forward, and we're working through that process.

All right. Congratulations on all the progress.

Thank you. Yes, it's very exciting.

And we have reached the end of the question-and-answer session. I will now turn the call back over to Cameron Reynolds for closing remarks.

So thank you, everyone. And I know it's been a long call. But as you can hear, we have a tremendous amount happening at Volition. And if you go through all the things we're doing, it's going to be a tremendously exciting year. I'd like to congratulate Tom and the entire Vet team for a fantastic outcome with the first very big deal signed and the first revenue in. And I think it's going to be a fantastic 2022. So please keep a close eye on what's going on. And thank you again for your time.

Thank you again for participating in today's conference call. You may disconnect your lines at this time. Thank you.