Quanterix Corp

NASDAQ:QTRX

Earnings Call Analysis

Record Consumables Production and Revenue in Q4 2023

In the final stretch of 2023, the company achieved a milestone with record consumables production, translating to a significant $17.5 million in revenue. This was a major thrust behind the total revenue of $31.5 million for the quarter. With a concerted effort grounded in a corporate transformation initiated six quarters prior, the company honed in on three pillars: quality, innovation, and strategic positioning for market value creation. The fruits of this shift are evident in improved gross margins, which shot up by 515 basis points year-over-year in Q4, alongside a striking reduction in cash use to $6.4 million—bolstering financial robustness with over $320 million in liquidity prepared for growth investments.

Comprehensive Growth and Operational Discipline in 2023

Throughout 2023, the company's steadfast focus on its transformation yielded impressive results: newly formulated assays enhancing margins; testing capacities and manufacturing outputs soaring by 50% and 300% respectively; and the capacity to triple these numbers if needed. Revenue grew by 16% over the year, reaching $122.4 million with a large chunk coming from North America (62%) and significant contributions from Europe (26%) and Asia-Pacific (12%). Additionally, the company successfully trimmed down its cash burn by a notable $40 million relative to the previous year, demonstrating strong operational discipline and efficient financial management.

Poised for Expansion with Strategic Focus in 2024

Looking into 2024, the company is poised for further expansion with strategic foci on growing its assay menu, fostering new tech innovations, and breaking into Alzheimer's disease diagnostics—a market ripe for disruption. The expectation is to roll out approximately 20 new assays by year's end, capitalizing on the surging demand for such products and services. On the financial front, the company anticipates a healthy revenue growth with forecasts between $139 million to $144 million, while keeping a watchful eye on emerging opportunities in diagnostics—a segment not currently factored into guidance due to its nascence.

Investment in Strategic Priorities amid Increased Cash Usage

With capital allocation in 2024, the intent is to vigorously pursue opportunities across the menu, tech, and diagnostics domains. To this end, projected full-year cash usage is poised between $25 million to $30 million, with an earmarked $5 million to $10 million for product and technology development, and $10 million to $15 million funneled into diagnostics ventures. Despite an uptick in cash usage, prudent financial steering is expected to moderate this through a projected $10 million reduction in cash burn, driven by revenue expansion and gross margin improvements. The overarching strategy is to align capital outflow with evolving market landscapes and invest diligently to fuel growth trajectories.

Company's Mission and Value Proposition

The underlying ethos driving the company’s trajectory is its mission to empower scientific discovery and improve patient outcomes. This creed serves as the guiding principle behind their endeavors—a commitment that has evolved from mere words to tangible actions, with the team in a proactive 'delivery mode' to make a real-world impact.

Earnings Call Transcript 2023-Q4

[Operator]

Good day, and thank you for standing by. Welcome to the Quanterix Corporation Q4 2023 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vandana Sriram, CFO. Please go ahead.

[Vandana Sriram, executive]

Thank you, and good afternoon. With me on today's call is Masoud Toloue, President and CEO of Quanterix.

Before we begin, I would like to remind you of a few things. This call will be recorded, and a replay will be available on the Investor Relations section of our website.

Today's call will contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act. These forward-looking statements are based on management's beliefs and assumptions and on information available as of the date of this call. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The risks and uncertainties that we face are described in our most recent filings with the Securities and Exchange Commission.

To supplement the company's financial statements presented on a GAAP basis, the company has provided certain non-GAAP financial measures. Management uses these non-GAAP measures to evaluate operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in its business. The company believes that such measures are important in comparing current results with other period results and are useful in assessing the company's operating performance. The non-GAAP financial information presented here should be considered in conjunction with and not as a substitute for the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP financial measures set forth in the appendix of the presentation posted to our website and in the earnings release issued today.

I will now turn the call over to Masoud.

[Masoud Toloue, executive]

Thank you, Vandana. Starting with Q4 of 2023, we hit record consumables production, delivering $17.5 million in revenue, contributing to $31.5 million of total revenue. Non-GAAP gross margins improved 515 basis points versus fourth quarter prior year, and cash use was $6.4 million, leaving us with over $320 million of liquidity on our balance sheet and in a strong position to deploy capital for growth investment.

As a reminder, we began a corporate transformation process 6 quarters ago with a focus on 3 core principles: quality, innovation and positioning Quanterix to unlock the value of the [translational] markets. In '23, we built newly-formulated assays, improving margins and manufacturability. Testing capacity in our accelerator and manufacturing output improved by 50% and 300%, respectively, each with new capacity to grow threefold from where they are today. New assays rolling off production lines are now getting into the hands of our first customers.

These accomplishments over 6 quarters are the result of our team's focus, determination and strong operating discipline. The efforts have positioned us for better quality, higher throughput, faster innovation and are reflected in our financial performance for '23, with revenue growing 16%, non-GAAP gross margin improving over 1,300 basis points, all while we reduced cash burn by $40 million in '23 as compared to '22.

In 2024, our 3 strategic objectives are growth in menu, new innovation in tech and Alzheimer's disease diagnostics. Starting with the first objective, we intend to leverage our newly-built product development engine by introducing approximately 20 new assays by the end of this year. This is not a small feat. Second, we're allocating resources to expand our technology platform. While 4- to 5-plex satisfies the vast majority of neuro programs today, our goal is to have Simoa not just in specialty neuro labs, but Simoa in all labs.

We're working on multi-channel lossless resolution, which means no loss measurements of the lowest quantity of protein that can be distinguished from the absence of that protein across multiple channels. Developing this would be a significant breakthrough. Expanding plex, maintaining sensitivity, improving footprint and reducing cost will enable research and clinical work in immunology and oncology laboratories. I expect we'll discuss more toward the end of the year.

Finally, on diagnostics, our stated goal is to build the global testing infrastructure for Alzheimer's disease. Identifying patients by invasive methods, including PET and lumbar puncture, is not scalable and limits access to newly-available Alzheimer's disease-modifying therapies. There's now abundant evidence showing non-invasive testing methods using blood-based biomarkers are equal to or better than invasive methods, and we believe they will be the best solution for broadening access to therapies to patients.

It has also become clear that identifying patients early in a disease cascade results in better patient outcomes. And this is where we believe Simoa technology will play a critical role.

I want to make an important point here. Simoa digitally interrogates proteins and femtoliter wells, providing exquisite signal-to-noise separation and amplitudes a couple orders of magnitude beyond noise floor where their technologies reside. The combination of ultra-sensitivity and precision enables much lower limits of detection and quantitation than other technology.

So as part of a diagnostic follow-up, if a Simoa p-Tau 217 test is used throughout the diagnostic workup, a physician can track a patient's levels if symptoms progress or if they undergo treatment. Other tech may not have the sensitivity or precision to do this across the full range of p-Tau 217 concentrations that are diagnostically relevant.

Precision at the very low concentration levels that p-Tau 217 is present in blood allows Simoa assays to provide high diagnostic accuracy, given the need to resolve small changes around cutoffs corresponding to low and high likelihood of amyloid pathology. Our test uses a 2-cutoff design, as recommended by the NIA-AA and other expert groups, providing high confidence result, extending to both ruling in and ruling out amyloid pathology. This has the potential to reduce approximately 70% to 80% of PET scans and lumbar punctures during the Alzheimer's diagnostic process.

Over the next 2 years, we will allocate $20 million of capital to advance the access of our diagnostic tests. We will also focus our clinical studies for diagnostics in 2 main areas: one, development and validation of a multi-marker blood test, and prospective studies with health systems to establish blood-based biomarkers as part of a routine Alzheimer's diagnosis and treatment.

For the multi-marker test development and validation, we're wrapping up the first 2 phases of 2 important studies, BioHermes and CANTATE. BioHermes is a prospective study that enrolled individuals from 17 sites across the U.S., including significant numbers of underrepresented populations and collected blood samples as well as PET images. Phase I of the study is now complete and with publications expected later this year.

CANTATE is our ongoing collaboration with researchers at the Amsterdam Medical Center, where blood is being collected, as well as CSF, with corresponding biomarker measurements to assess amyloid. We expect to announce results from Phase I of these studies later this year. Quanterix is also sponsoring and taking part in several new studies to establish blood biomarkers as part of routine Alzheimer's diagnosis and treatment. In addition to helping expand the adoption of laboratory-developed tests based on Simoa technology, such as plasma 217 and our planned future multi-marker test offering, these studies are expected to provide clinical validation data to support an FDA submission for an Alzheimer's blood biomarker diagnostic.

In 2024, we will focus our efforts on building out our commercial capabilities to support diagnosis of Alzheimer's disease and what we would expect to be a corresponding uptick in the adoption of new therapies. We've already on-boarded a dedicated commercial team, and they've hit the ground running. We're pleased to announce that we're now working with 5 leading health networks in the U.S., an important step as we build out the infrastructure that supports testing for this disease. Each will have access to the LucentAD tests at our CLIA-certified lab, or our instruments and assays to develop and validate their own laboratory-developed tests. These networks will provide reach to over 140 hospitals carrying for approximately 21 million patients.

I will now turn the call over to Vandana to cover our financial results.

[Vandana Sriram, executive]

Thank you, Masoud. I will now cover additional details of our fourth quarter and full-year performance and will provide guidance for 2024. As Masoud mentioned, the 2023 year-end capped our corporate transformation, and we've made significant execution progress over the 6-quarter program.

Our total revenue for the fourth quarter 2023 was $31.5 million, an increase of 22% from the fourth quarter of 2022. Our consumables revenue increased to $17.5 million, or 56% compared to the fourth quarter of last year. This was a record quarter, and we noted continued strong demand for our consumables offering coming from high interest in supporting neurology.

Instrument revenue was $3.3 million, a decline of 39% over the fourth quarter of 2022, similar to other tools companies and continuing the trends we saw in the second half of 2023. We added net 20 instruments to our install base in the fourth quarter of 2023.

Fourth quarter revenue from our Accelerator Lab was $5.6 million, an increase of 71% over the fourth quarter of 2022. We continue to observe strong demand for our accelerated services, and this has been especially valuable to us in the current environment where tools have been capital-constrained, very unique in our industry in that CapEx pressure has not limited customer access to our Simoa technology. When the budget environment changes to be more favorable to capital purchases, we expect some rebalancing of instrument and service mix.

Moving on to gross margin for the quarter, our GAAP gross profit and margin was $16.8 million and 53.2%, respectively, for the fourth quarter of 2023 compared to $12.6 million and 48.8%, respectively, in the fourth quarter of 2022. Non-GAAP gross profit and margin was $14.7 million and 46.5%, respectively, in the fourth quarter as compared to $10.7 million and 41.3%, respectively, in the fourth quarter of last year. The year-over-year margin expansion reflects the impact of our transformation efforts and favorable mix from increased sales of higher-margin consumables and accelerated services.

Our fourth quarter 2023 GAAP operating expenses were $33.7 million compared to $34.5 million in the fourth quarter of 2022. The fourth quarter of 2023 included one-time impairment and restructuring charges of $1.6 million, primarily from a lease impairment as compared with similar charges of $9 million in the corresponding prior period. Excluding the impact of impairments, GAAP operating expenses increased $6.6 million, and non-GAAP operating expenses increased $6.4 million due to higher R&D and personnel-related costs.

Our operating loss declined from $22 million in the fourth quarter of 2022 to $17 million in the fourth quarter of 2023 due to higher consumables and accelerated sales and improved gross margins. For the full year, these results bring us to $122.4 million of revenue, delivering 16% growth.

Now I will provide some additional context on full-year revenue. 62% of our revenue came from North America, 26% from Europe and 12% from Asia-Pacific, with mid-teens growth across all geographies. Over 80% of our revenue came from neurology, where we continue to have a highly-differentiated position.

Moving on to liquidity, we ended the fourth quarter with $323.9 million in total cash, cash equivalents, marketable securities and restricted cash, a net usage of $6.4 million during the quarter as compared to cash usage of $5 million in the fourth quarter of 2022. For the full year, our cash usage was $17.4 million, a reduction in cash usage of $40.3 million. We continue to have a strong balance sheet, with ample cash to fund growth.

Let's turn to guidance for 2024. We expect full-year revenue in 2024 to be in the range of $139 million to $144 million. This guide is for our research-only business and does not include revenues from diagnostics testing, which to date have not been material. Diagnostics is a nascent area closely correlated to therapy adoption and, at this time, it is premature to provide guidance. However, with the commercial team that is now in regular contact with neurology centers and hospital systems, we are in a unique position to measure blood testing uptake, and we will provide quarterly updates on our progress.

For the full year, we expect GAAP gross margin to be in the 57% to 61% range and non-GAAP gross margin to be approximately 51% to 55%. As with revenue, this guide excludes margins from diagnostics testing.

Lastly, on to capital allocation and cash usage. We expect our cash usage for the full year to be in the range of $25 million to $30 million, an increase in cash usage of approximately $10 million at the midpoint. As Masoud mentioned, our priorities in 2024 will be growth in menu, innovation in tech and ramping up diagnostics. We will spend approximately $5 million to $10 million on the first 2 initiatives and approximately $10 million to $15 million on diagnostics, with additional spend on diagnostics expected in 2025. This approximately $20 million investment in our strategic initiatives will be offset by approximately $10 million of reduced cash burn from revenue and margin growth.

We will continue to drive our RUO business to reduce cash burn and still expect to achieve cash flow break-even on this business at approximately $170 million to $190 million of revenue. This guide includes the incremental investment in menu and innovation. At the same time, we will invest capital to grow diagnostics and, consistent with our comments on revenue, it is premature to provide a cash flow break-even point for diagnostics.

In summary, we are aligning our capital allocation priorities to our areas of opportunity, and we will put our capital to work to drive growth in these exciting areas.

I will now turn it back over to Masoud before we take your questions.

[Masoud Toloue, executive]

Thank you, Vandana. I want to say we're very proud of the talent density at Quanterix. It's the super team who has made difficult and painful changes in the company. This would not have been started or completed if we did not believe in the output of work. Our mission is to provide the tools to enable discovery and improve patient outcomes. This is not just a statement that goes on a Web page or wall. It is very real and tangible, and our team is in active delivery mode.

Now we can take some questions.

[Operator]

Thank you. [Operator Instructions] And our first question is going to come from the line of Matt Sykes with Goldman Sachs.

[Matthew Sykes, analyst]

Maybe just starting out, I want to go back to the announcement you guys made on Monday about the health systems. And just a couple of things. One, is that included in the guide? I'm assuming that's the diagnostics portion that you're not including. And 2, how do you think about, 1, sort of the timing of that revenue coming through? And the other point is, in terms of the mix, I know you had said it could be instruments assays, Accelerator Lab. How are you thinking about the potential mix of that partnership, over time? And I've got a follow-up.

[Masoud Toloue, executive]

So yes, I think the partnership announcements we had a couple days ago was super-exciting. And [it did] 2 things. One, the versatility of our offering is twofold. First, we're able to offer the platform and the testing, the 217 test, and enable hospitals to do their own testing. But at the same time, we're also enabling access to our Accelerator Lab, where hospitals or physicians can send samples to the Lucent lab, and we're able to offer services there. So it's a really unique offering, and we're able to keep in touch with neurologists and really stay up-to-date on the latest of what's happening.

You're right in that this is diagnostics revenue that's not imputed in the guide, or not put into the guide. Right now, we're not including guidance for diagnostics.

And then from, I mean, mix perspective, are you referring to the mix on test send-out versus [enablement], or some other?

[Matthew Sykes, analyst]

Yes, that mix, but sort of how many do you expect to buy instruments do it themselves? How many do you think will send out to you? And where do you think the bulk of the revenues could come from for this partnership?

[Masoud Toloue, executive]

Yes, that's a good question. I mean, the 5 that we listed, there's different ranges. So some of them are going to start as test send-out as they're putting together a platform and getting their tests up and ready at their own laboratory, and then some want to offer testing right off the bat with our platform. So it's a little bit of a mix, and it's still early to get a good sense of how that's going to shake out for the year.

[Matthew Sykes, analyst]

And then maybe for Vandana, maybe some color on the balance of sort of consumable versus instrument versus lab services within that 2024 guide. How do you see that kind of shaking out? I know you made some comments on the capital equipment environment, which we're all very well aware of, but just any color on what you perceive to be that mix shift over the course of the year?

[Vandana Sriram, executive]

Yes. So at this point, we're really looking at 2024, at least in the first half, being very similar to the mix that we saw in 2023, so still expecting to start the year with some amount of constraints on the instrument side. But again, seeing really, really good demand on the accelerator side. We have a lot of interest and a lot of, I'd say, quoting activity going on right now for accelerators. So we continue to see accelerators to be really strong, and consumables also come out pretty strong.

Now consumables, the initial part of the year will be all about converting customers to the new assets, so we expect there to be some transition period there where we will have to support customers on the older assays and then eventually bring them on to the new assays. So there might be some amount of choppiness in the first quarter as we get through that. But from that point onwards, we expect consumables growth to be really steady.

[Operator]

And our next question is going to come from the line of Puneet Souda with Leerink Partners.

[Puneet Souda, analyst]

So a couple of questions here. Maybe first on just FDA submission, what does that look like and the timing of approval, p-Tau 217, what sort of traction you're seeing there? And should we assume that that will be one of the standalone tests, or it would be a multi-marker test that comes out of FDA? I recognize it's 217 at the LDT already. So just want to understand sort of how you're contemplating FDA approval for the product. And then I have a follow-up.

[Masoud Toloue, executive]

Yes. Puneet, thanks for the question. So 217, as you said, it's already in LDT. We've committed to submitting the 217 biomarker to the FDA this year. We've begun some discussions. All of our clinical trials, or the prospective trials that we're running, are designed to get additional data and validation for IVD submission on 217. And that's something we're going to do this year.

And from a multi-marker standpoint, we've also said that, in '24, we'd released a multi-marker LDT as well as then, in the future, do something on IVD for multi-marker. But from a sequencing standpoint, we have the 217 LDT today, FDA IVD submission, multi-marker LDT, and then subsequent submission for that. And so the BioHermes, the CANTATE and then a couple of new collaborations we're working with now all provide clinical evidence development for not just IVD but reimbursement in the future.

[Puneet Souda, analyst]

And then maybe a bigger question here is, based on the feedback that you're getting from the field already, can you talk a little bit about how do you see the adoption for the 217 LDT? I know you have commercial folks out there already in collaborations with some of the larger centers. I think the bigger question here is with Leqembi and donanemab, expectations for the Street have come down. They have settled. But I'm just trying to get a view as to what you're hearing versus should we look to the drug adoption to see how things trend.

[Masoud Toloue, executive]

Yes. I think it's hard to say exactly how this correlates, but I think drug adoption is probably a decent proxy for just testing patients. That being said, when we are speaking to neurologists and these hospitals, one of the main things that comes across is just the demand and need for additional tools. And there, it's incredibly clear that, I mean, the data speaks for itself at the 217 test, the superior to any other biomarkers out there. And if you're doing a study and you want to look at a patient at the very early stages and monitor them over a period of time, you need a solution that's going to be able to look at levels that are fairly low and that require high sensitivity, all the way in the lifecycle as blood levels of this 217 increase. And so that's clear, and that's what we're hearing.

Also, recall that a good part of our business is clinical trial work, having additional efforts with pharma companies that are looking at combinatorial therapies, other Alzheimer's therapies, and we expect that to have a research tailwind as well as more and more clinical trials. So from a patient measurement perspective, I think drugs are a decent proxy. We'll follow that, and we will have more information as the year goes. But we think that, with these new therapies, it's just a start for Alzheimer's.

[Puneet Souda, analyst]

And then just my last one on the RUO technology that you talked about, the multi-channel lossless resolution. Can you just remind us what plex you're targeting for that?

[Masoud Toloue, executive]

Yes. I would say mid- to low-plex. I mean, one of the key guiding principles of Quanterix is that we're very translational. So we're involved in identifying these markers and the translation of them, support of these markers for therapies, and then eventually testing and diagnostics. And so, when you look at what or how you do that, it's usually anywhere from where we are today, 1 to 4 or 5 plex to 2x, 3x more than that. And anything more than that really becomes a discovery application, and we're more on the translation side. So that's where we're focusing when we look at future technology.

[Operator]

And our next question is going to come from the line of Kyle Mikson with Canaccord Genuity.

[Kyle Mikson, analyst]

I want to ask a longer-term question for you, Masoud, and that is the path to reimbursement for the neurology test portfolio. I guess this is a multi-part question. So what's the current plan, the plan to this point, including the CPT that's expected in this year? Second, there's other companies with protein-based test with Medicare coverage, but how does the recent MolDX Proteomics LCD kind of impact Quanterix possibly? And third and finally, you're not trying to get approval for LucentAD p-Tau 181, but are you still trying to get reimbursement for that test? Like, how would all this work for that, particularly because that's more of a near-term thing?

[Masoud Toloue, executive]

Yes. So from a reimbursement standpoint, as you stated, we're seeking a CPT for our Alzheimer's blood biomarker, specifically the 217 protein. It's now really abundantly clear that 217 is a superior marker versus 181. So a lot of our focus has shifted on 217 when it comes to testing. That being said, 181 is still available as that LDT, and there's a lot of interest in clinical trial work for 181, and so that's still there. But from a reimbursement standpoint, we've put some of our focus on 217.

Now, that's the first step. And then, as we're doing all this work with this prospective study and our collaboration with the VUMC on CANTATE, [indiscernible] there is a multi-marker algorithm, so several markers together that could provide a differential diagnosis and maybe potentially sensitivities that could be greater than any single biomarker. And then, that's its own reimbursement schedule.

From your question on MolDX, we were super-pleased that these multi-marker algorithms are picked up. MolDX is obviously well-respected, and that read-through was very important. We think it's important for the field and validates the path we're on.

[Kyle Mikson, analyst]

Just actually another one on, I guess, diagnostics. First, just confirm, please, if the 217 test has enough data for the approval, for reimbursement. I know you got the CANTATE and BioHermes. Is that going to be enough, do you think? And one for Vandana.

[Masoud Toloue, executive]

Yes. We are very confident with the 217 results. We've published a white paper with some results that we have on BioHermes, the Amsterdam cohort together. And so, when you combine those 2 cohorts, we looked at something over 850 patients. And we had [sensen] spec above 90% across the board with accuracy that rounded up to around 91%. So we think the data for 217 is solid.

[Kyle Mikson, analyst]

And final one for Vandana. I think the guidance is something like maybe $10 million to $15 million or so assumed for diagnostic spending for investment in '24. That means, like, I think it's about $5 million for '25. If you could just walk through how you're allocating diagnostic investments specifically, that would be interesting to hear for the next, I guess, 2 years. And then secondly, just hypothetically, if you get any diagnostic revenue this year, [would] that coming out of the negative gross margin?

[Vandana Sriram, executive]

Yes. So on diagnostics, we had signaled earlier that we will spend a total of approximately $20 million between '24 and '25. For 2024, most of that spend is on the commercial side. So we've already onboarded our team. That happened [very late] last year, so we'll have a full year of cost for that team. as well as everything that's needed to really get the message out and to get the right traction around the commercial [team]. There'll be some amount of infrastructure costs to get billing ready and all those kinds of things, but it's primarily getting feet on the street and getting that going.

And then, similarly for 2025, we expect the costs to be along those lines, really more to support what it takes to get the reach of the test out. We think we have enough capacity [at accelerators]. We don't think there's much more needed from a footprint perspective.

Having said that, one thing I do want to add is we're somewhat fortunate that we have a strong balance sheet. So we're going to pace the diagnostics opportunity as it develops. If it moves faster and it's worthwhile to spend more money on it, we'll move a lever. If it's moving slower and we need to pull back, we can do that, as well. So we'll continue to face this, but this is kind of our broad framework for now.

And then, to your question on margin on diagnostics, we don't expect margin at this stage to be negative or overly dilutive to our portfolio. But we just don't know enough about it right now. So as we gather more information, and as we start to see more tests come back in, we'll have a better sense of what it looks like.

[Operator]

And our next question is going to come from the line of Sung Ji Nam with Scotiabank.

[Sung Ji Nam, analyst]

So just on the CANTATE and BioHermes studies, you touched on it a little bit, but could you kind of elaborate on what are the endpoints being measured? Or what questions are being asked for the Phase I of the trial, and then what are the next steps for both trials?

[Masoud Toloue, executive]

So the clinical sample sets that we look at include patients with MCI and AD dementia, and that's through the Amsterdam dementia cohort. And then there was recruitment of individuals with MCI and mild AD in the BioHermes trial. So the ADC, or the Amsterdam cohort, our memory clinics where they looked at CSF; and then the BioHermes, they had PETs for amyloid status. So each of those patients received CSF or PET, and they were compared to our test from a diagnostic standpoint. And then, using those, we establish clinical thresholds and came up with the specs of our platform of our test. And so that's Phase 1.

And then, what we're doing is, on the second phase for CANTATE, we're enrolling patients for memory centers, prospective patients for memory centers, to be able to look at this [in a] multi-marker setting, so going beyond just single marker, but testing 4 markers or up to 5 markers at once.

[Sung Ji Nam, analyst]

And then, just was curious, you mentioned in the press release that Eli Lilly launching their p-Tau 217 blood-based diagnostics on the Quanterix platform. Are they using other platforms as well? Or are they pretty much just solely using the Simoa platform for now?

[Masoud Toloue, executive]

Yes, we're only aware of the Simoa platform for their 217 diagnostic test. I think published some very interesting data at the last conference. It was a nice poster presentation that they had. So that's all we're aware of.

[Sung Ji Nam, analyst]

And then, just lastly on the new platform under development, the increase [indiscernible], is that based on the Simoa platform or the planar array platform? Or is it something totally different?

[Masoud Toloue, executive]

Yes. It's based on the Simoa technology and the Simoa platform. So it's the single molecule resolution but lossless sensitivity across multiple channels. So typically, when people look at things and you start to multi-plex, you lose resolution as you add [plexes]. And so our goal with high sensitivity and precision for these key biomarkers is to make it lossless. And so it's based on that platform and the original technology, which was invented in the Walt lab.

[Operator]

[Operator Instructions] I'm showing no further questions. This is going to conclude today's question-and-answer session. This is also going to conclude today's conference call.