Adaptive Biotechnologies Corporation (ADPT) Q2 2020 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by and welcome to the Adaptive Biotechnologies Second Quarter Financial Results Conference Call. At this time all participants are in a listen-only mode. After the speakers presentation, there will be a question-and-answer session. [Operator Instructions]. Thank you. I would now like to hand the conference over to your speaker today, Ms. Karina Calzadilla. Please go ahead.

Thank you, Tino. And good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies second quarter 2020 earnings conference call. Earlier today, we issued a press release reporting Adaptive financial results for the second quarter of 2020. The press release is available on our corporate website at www.adaptivebiotech.com. We are conducting a live webcast of this call, a replay of which will be available on our website after its conclusion. I would also like to remind you that during the call, management will make projections and other forward-looking statements within the meaning of federal securities laws regarding future events and the future financial performance of the company. It is important to note that these statements reflect management's current perspective of the business as of today's date. Actual results may differ materially from current expectations and projections, depending on a number of factors which are set forth in our public filings with the Securities and Exchange Commission, including the Form 10-Q to be filed today. Adaptive disclaims any intent or obligation to update these forward-looking statements, except as expressly required by law. In addition, non-GAAP financial measures will be discussed during the call. Our GAAP financial metrics and reconciliation from non-GAAP to GAAP metrics can be found in our earnings release issued earlier. Joining the call today are Chad Robins, our CEO and Co-Founder; Julie Rubinstein, our President; and Chad Cohen, our Chief Financial Officer. In addition, Harlan Robins, Adaptive's Chief Scientific Officer and Co-Founder, will be available for Q&A. With that, I will turn the call over to Chad Robins. Chad?

Thanks, Karina. Good afternoon, everybody. And thank you for joining us on our second quarter 2020 earnings Call. I hope that you and your loved ones are staying safe and healthy as we continue to navigate through these difficult times. I want to start off by saying I'm truly honored to be part of the Adaptive team and want to congratulate my colleagues on our first year anniversary from our IPO. The past months have been challenging for everyone and our entire company has shown unwavering dedication and flexibility. Thank you to all our Adaptive employees. As you all know, the current coronavirus pandemic is highlighting the critical importance of understanding immune response to disease broadly, making Adaptive's technology more relevant than ever. At Adaptive, we're focused on translating the genetics of the adaptive immune system into clinical products to detect and treat disease. And we are committed to leveraging our immune medicine platform to support the efforts to combat COVID-19 pandemic. COVID-19 brought the role of the immune system to the forefront of society, and has created the opportunity for Adaptive to be positioned as the go-to company to rapidly and reproducibly assess the T cell response to any pathogen, including future pandemics. The breadth of advances we have made recently in each of our business areas is remarkable, particularly given the impact of COVID on all of us. Among the main highlights, we reported revenues of $21 million, above our pre-announced revenue range associated with our follow-on offering. In our research business, we launched a new product immunoSEQ T-MAP COVID to elucidate the T cell response to vaccine in development for COVID-19. In our clonoSEQ business, we achieved an important milestone with a label expansion into CLL, our first FDA approval for blood based testing. For immunoSEQ Dx, we initiated two clinical validation studies, the ImmuneSENSE study for Lyme disease, which started enrolling in time for Lyme season and the ImmuneRACE study to collect blood samples from COVID-19 impacted individuals. We also published two manuscripts, which had been submitted for peer review, and details the largest global effort to map the T cell response to COVID-19 for research and diagnostic purposes. Today, we are also pleased to announce favorable results from our head to head study comparing immunoSEQ Dx, SARS-CoV-2 to two leading serology tests to detect past infection in 100 convalescent patients in a real world setting. #in drug discovery related, to our TCR efforts, we continue our activities on the first shared product to support Genentech in an IND submission with the FDA. Our BCR efforts, we have selected and are synthesizing over 2,000 candidates to identify those that best neutralize SARS-CoV-2 for Amgen to evaluate this fall. As you can see, we are firing on multiple cylinders and recently completed our first follow-on equity raise to enabled continue aggressive deployment of capital into our platform. The financing delivered approximately $271.7 million in net proceeds to our balance sheet and will allow us to incubate our long-term focus on value creation for our shareholders. Now, I want to give you an overview on our T cell based efforts to respond to COVID. The scientific community has always known that the T cell response is important in the overall study of the immune response. However, it has always been difficult to study T cells because of the massive diversity of HLA dependent T cells to help your body respond to hundreds of millions of different pathogens. Therefore, most researchers, including vaccine developers, have continued to rely on techniques to either measure the immune response solely based on antibody levels or sometimes using T cell techniques that are expensive, bespoke and low throughput. At Adaptive, we set out to solve this problem several years ago. When this pandemic hit, together with Microsoft, we created the ImmuneCODE program to map the T cell response to SARS-CoV-2 across the population. Our goal was to leverage the existing capabilities of our high throughput platform to generate an unprecedented amount of T cell data from over 4,500 patients to understand the adaptive immune response to COVID. In June, we launched the ImmuneCODE database to make the first release of these data publicly available and continue to add to the database as we obtain and analyze more samples. To date, we have sequenced over 1,400 patient samples. From these samples, we have mapped over 135,000 high confidence T cell receptors or TCRs to the spike protein as well as 10 other specific parts of the virus, which we have shown to be most immunogenic. We've also demonstrated that these PCRs have promising durability since greater than 90% of patients had shares to SARS-CoV-2 specific T cells after 90 days post confirmed diagnosis, the maximum time period currently available to assess response. As a result, we launched immunoSEQ T-MAP COVID as a tool to offer vaccine developers a way to integrate our map of SARS-CoV-2 specific T cells into their vaccine trials. This is the first molecular T cell monitoring tool for SARS-CoV-2 that accurately and reproducibly measures the T cell immune response to vaccines and tracks the persistence of that response over time. Finally, from the mapped TCRs, we are curating a set of TCRs that are shared across the population, creating an enhanced T cell receptor signature or classifier to use for diagnostic purposes. We currently refer to this as immunoSEQ Dx SARS-CoV-2. To begin with, we believe that this may offer an alternative test to confirm past infection based on the T cell response since we are all learning that the patient's antibodies don't seem to tell the whole story. As I mentioned earlier, we recently demonstrated higher sensitivity versus two leading serology tests in a real world study with 100 convalescent patients. We are very encouraged by these data and believe that they will contribute to our overall understanding of the immune response to COVID-19. These additional data will be published shortly and Julie will provide more details in her remarks. I've never felt more privileged to be part of the broader healthcare community and the biotech industry. It's been incredibly motivating to see not only the work of my colleagues at Adaptive, but also many entities proactively collaborating to solve this global pandemic. With that, I'll hand over to Julie to walk you through more detail across each of our product areas. Julie?

Thanks, Chad. And thanks to all of you for joining us today. I really hope you and your families are safe and healthy. I want to echo Chad's thanks to our incredible employees. It has been a busy and successful quarter during an uncertain time. Starting with our clinical diagnostic product, clonoSEQ. As Chad mentioned, we recently got FDA clearance for our first clonoSEQ label expansion in CLL in blood as well as bone marrow. This marks an inflection point within our clonoSEQ as it is our first approval in blood and doubles the size of our addressable population under our FDA label. Importantly, it will also support our expansion into the community oncology setting where most patients with CLL are treated. In addition, we launched a service offering which will enable clonoSEQ patients to safely obtain blood draws outside of their doctor's offices, given the risks that COVID-19 poses for cancer patients. Now, patients can access minimal-contact blood collection services at any of the nearly 2000 LabCorp patient service centers in the United States. Or they can have a blood draw performed in the comfort of their own homes through Adaptive's collaboration with Phlebotek Solutions, a nationwide provider of mobile phlebotomy services. Following our launch of CLL in blood, we will continue to expand into blood testing in ALL and multiple myeloma, which enables an increase in the number of tests run per patient. Ultimately, we plan to expand the use of clonoSEQ into NHL. These efforts, coupled with increased payer coverage and patient engagement, set the stage for clonoSEQ's growth trajectory. ClonoSEQ sequencing volumes grew 31% to 3,136 tests versus prior year. These volumes speak to the value of clonoSEQ MRD testing and to our ability to maintain customer engagement even though clinical care is significantly restricted for cancer patients given the pandemic. In fact, while some of our traditionally higher order volume accounts remain closed, we are seeing more meaningful order volumes from new accounts, faster than we've seen before, giving us great confidence in the build out of our commercial infrastructure for clonoSEQ and our pipeline. April was our toughest month due to COVID and our volumes were down 30% versus March. Since April, we've grown sequentially month after month, back up to our March volume, which we have surpassed in July. That said, we will continue to monitor COVID-19 closely as clinical volumes may still be impacted due to resurgences in COVID cases around the country. Moving on to our research business with immunoSEQ. The research business was impacted the most severely in the quarter by COVID-19 as around nearly half of US labs still be remain closed. Sample arrivals have been slow since late March with continued variability month by month. That said, there are exciting things happening within our research business. As Chad mentioned, we announced the launch of immunoSEQ T-MAP COVID, an extension of our robust and proven molecular immuno sequencing product, immunoSEQ, which quantitates T cell receptors. The key new addition is that we are providing data that maps those receptors to SARS-CoV-2 antigen, a capability that may significantly improve the ability to measure the immune response to vaccines in development. This is the first time we have developed a software application on top of immunoSEQ to offer research customers a quantitative, reproducible list of T cell receptors mapped to specific disease antigens. Importantly, like we do with immunoSEQ, we are able to do this from a simple blood sample that does not require any special storage or handling. Since launch, we have engaged with many partners for immunoSEQ T-MAP COVID, including those already in late stage vaccine trials. We also believe that the information we have shared about the immunogenicity of various parts of the SARS-CoV-2 virus, including, but not limited to, the spike protein may inform next generation vaccine design and development. Now, moving on to our clinical pipeline with immunoSEQ Dx and drug discovery. For immunoSEQ Dx Lyme, we opened our ImmuneSENSE study to demonstrate the sensitivity and specificity of our tests in development in patients with signs and symptoms of suspected Lyme disease. The study will compare our T cell based diagnostic approach to current standard of care serology, which has a high false negative rate of 60% to 70% in the acute Lyme setting. We intend to enroll 990 subjects into the study, of which approximately 400 will have been clinically diagnosed with Lyme disease. The remaining subjects will be recruited as negative controls from both endemic and non-endemic regions. There are approximately 3.4 million Lyme diagnostic tests performed annually. Initially, we are focused on generating data that supports market entry for early and more accurate diagnosis of Lyme disease for patients with non-descript symptoms that are suspected to be caused by Lyme. This population is over 600,000 patients in the US each year. Data from the study for the newly diagnosed cohort will be collected first and will be the basis of our submission to the FDA planned for the end of this year. We will also be collecting up to four longitudinal samples for a year or longer to be able to answer questions about patients with recurring symptoms, even after standard antibiotic treatment. While we continue to monitor the pandemic and its potential impact on enrollment, we have implemented proactive efforts to mitigate delays including increasing the number of participating sites, introducing targeted digital marketing campaigns, implementing mobile phlebotomy and working with key Lyme advocate organizations to further drive awareness. For immunoSEQ Dx SARS-CoV-2, you heard from Chad that we have demonstrated that our T cell based diagnostic test performs favorably against two leading serology tests to detect past infection in a real world setting. More specifically, all three tests were run and compared across 100 real world convalescent patients from the ImmuneRACE studies. Results show that at 99.8% specificity for all three tests, our T cell test was 92% sensitive versus 90% and 87% for the other two serology tests respectively. It is important to note that, since our test is a self-learning diagnostic that leverages machine learning, the classifier will incrementally self-improve every time we sequence more samples, making the true sensitivity of our tests even higher. Based on these data, we are confident that our clinical validation study being designed currently with the FDA will give us a comparable label to serology tests, and we feel we will have a higher performing test in the real world. We plan to enter the market in the fall with a test to detect past infection that will be targeted towards consumers, employers and surveillance programs. This will allow us to build the foundational commercial and operational infrastructure needed to deliver this test. We anticipate that the data we continue to generate will expand the clinical use cases for our test to potentially include assessing preexisting immunity based on cross reactive T cells, post infection immunity and immunity from a vaccine, which may need to be monitored for possible boosters over time. I would like to highlight that the progress just described with Lyme and SARS-CoV-2 for immunoSEQ Dx not only solidifies our position within infectious disease, but also provides a proof of our immunoSEQ Dx platform for the early stage diagnosis of many diseases. Importantly, the accelerated activities around SARS-CoV-2 will allow us to bring our first immunoSEQ Dx product to market a year earlier than planned. Moving on to our drug discovery pipeline. We continue to leverage our immune medicine platform to enable the discovery and development of novel therapeutics, now including both TCR discovery for cellular therapies in oncology with Genentech and antibody discovery for neutralizing antibodies against SARS-CoV-2. On the first shared product with Genentech, we have delivered the data package for our lead TCR candidate against the selected shared antigen. IND submission by Genentech is expected in Q1 2021. We are adding TCR candidates to our true TCR library against both tumor associated antigens and neoantigens, which Genentech will continue to assess for additional shared products. We are also making improvements to our real time screening of TCRs from patient blood that establishes the end-to-end workflow for our private product. To support this program, we anticipate opening our South San Francisco dedicated prototype lab in Q1 of 2021. Regarding our efforts to identify neutralizing antibodies against SARS-CoV-2, we have selected more than 2,000 candidate antibodies from acute or recovered COVID-19 patients. Of these, the first 500 candidate antibodies are being characterized to confirm which antibodies will bind most strongly to the virus. We expect to have identified potent neutralizing antibody candidates to treat COVID-19 by the fall, at which point Amgen has an option to develop, manufacture and commercialize selected candidates. I'll now pass it over to Chad C, who will provide you with a financial update. Chad?

Thanks, Julie. Turning to our financial results, total revenue in the second quarter was $21 million, representing a decrease of 5% from $22.1 million in the same period last year. Our revenue mix for the second quarter consisted of 38% of our revenues coming from our sequencing category and 62% coming from our development category. Sequencing revenue in the second quarter was $8 million and decreased 33% from the same period in 2019. This decrease was primarily driven by a $4.8 million decrease in revenue generated from our biopharma and academic customers, partially offset by an increase in revenue generated by our clinical customers. Research sequencing volume, which includes sequences reported to both our biopharma and academic customers, decreased by 54% to 4,185 sequences from 9,084 sequences in the second quarter 2019. On the other hand, clinical sequencing volume increased 31% in the second quarter 2020 to 3,136. clinical tests from 2,388 clinical tests from the second quarter of 2019. Clinical sequencing volume did recover sequentially from April through June, returning back to our exiting Q1 volumes, although the initial impact of the COVID lockdown did slow our overall testing volumes on a sequential basis quarter after quarter. Development revenue grew to $13 million in the second quarter, up 27% from the same period last year. The increase was largely due to growth in revenue generated from our Genentech collaboration, which continued to accelerate in the quarter and led to higher development revenues than originally contemplated. Shifting now from our revenue to our operating costs. Total operating expenses for the second quarter of 2020 were $57.9 million, representing a 52% increase from $38.2 million in the same quarter last year. Working down our operating expenses, cost of revenue was $4.9 million during the second quarter 2020 compared to $5.7 million from the second quarter of last year, representing a 14% decrease. Lower cost of revenue was primarily driven by a decrease in sample volume, partially offset by increased labor and overhead costs. Research and development expenses for the second quarter of 2020 were $26 million compared to $16.5 million in the second quarter of 2019, representing an increase of approximately 57%. The increase was attributable to a number of key areas of focus. For example, we drove investments into our South San Francisco cellular lab to advance our drug discovery efforts where we nearly doubled the size of our team supporting that opportunity. We also invested heavily in our clinical product development team to support development of our initial immunoSEQ Dx applications in Lyme and COVID, as well as clonoSEQ label expansions in the blood. Sales and marketing expenses for the second quarter of 2020 were $14.3 million compared to $8.9 million in the second quarter of 2019, representing an increase of 61%. The increase was primarily due to the expansion of our commercial teams earlier in the year to support our clonoSEQ diagnostic, along with investments in both corporate and product marketing activities. These increases were partially offset by savings related to in-person customer events as we adapted to the virtual nature of these programs during the quarter. General and administrative expenses for the second quarter of 2020 were $12.2 million as compared to $6.7 million in the second quarter of 2019, representing an increase of approximately 84%. The increase was driven primarily by increased headcount and costs associated with being a public company. Net loss for the second quarter of 2020 was $33.5 million compared to second quarter 2019 net loss of $15.7 million. Adjusted EBITDA for the second quarter of 2020 was a loss of $28.5 million compared to a loss of $10.9 million in the same period of the prior year. Due to the ongoing uncertain nature of COVID, guidance will remain withdrawn at this time. We ended the second quarter of 2020 with approximately $628 million in cash, cash equivalents and marketable securities and we had no debt. On a pro forma basis, adjusting for the net effect of our recent equity raise, our cash on the balance sheet would be approximately $900 million. With the existing and new capital on hand, our balance sheet is now commensurate with a large opportunity that emanates from our immune medicine platform and will allow us to incubate our current or future opportunities. Before I turn it over to Chad for his closing remarks, I want to reiterate that one of the key benefits of having a platform technology is that we can rapidly scale into new areas of disease by applying our existing infrastructure to new opportunities. This approach provides us with significant economic advantages that we expect to leverage over the long term. I'd like to turn the call back to Chad for his closing remarks.

Thank you, Chad. As you can see, our platform continues to be an open ended growth story. We were executing on multiple fronts and, importantly, we're delivering on our promises. The world is now on notice that the immune system is key to understanding disease. And our immune medicine platform has removed the technological hurdle to include the T cell response to disease at scale. We believe this will fundamentally change immunology. Our future is bright and I can't be more enthusiastic about what we can accomplish. With that, I'd like to turn the call back to the operator and open it up for questions.

[Operator Instructions]. For the first question, we do have Derik de Bruin from Bank of America.

A couple of questions, if I may. I guess the first question is, can you talk a little bit about how you're thinking about pricing on both the vaccine side and sort of the opportunity there for drug development? And then also, on the commercial serology test, if you look at some of the other commercial serology tests out there, they're fairly inexpensive and reimbursement for standard tests is around $42, I believe. And, obviously, your test is not going to be in those ranges, given everything that's involved with it. So, can you talk a little bit about the reimbursement opportunities, how you're looking at this just so we can get a better sense with it? And the question is, any initial conversations about how payers are looking to – have you had any conversation with payers at this point? Thanks.

Julie, do you want to take immunoSEQ T-MAP COVID?

Sure. Absolutely. Hi, Derek. So, the way we're thinking about pricing for immunoSEQ T-MAP COVID, it's really an extension of our existing fee for service offering for immunoSEQ where we're really keeping it in line with the way that we currently work with our pharma partners. And that pricing is broken into two components. One is a per sample sequencing fee. And the other is what we call a technology access fee for the data analysis. We're actually keeping the per sample sequencing price the same because it's the same – your blood sample that we typically run and we're increasing the technology access fee to enable annotations from the antigen map. So, we see this as, hopefully, a nice seamless way to continue the work that we already do with most of these companies and really treating it as an extension of our existing sort of bread and butter immunoSEQ offering.

And with respect to immunoSEQ Dx COVID, we're currently in discussions with payers. We're discussing pricing across the board. Right now, we recognize that a sequencing test by nature is going to be a more expensive test than an antibody serology test. However, we also do believe, as was mentioned during the script, that this is just the first kind of data and we believe that our results are going to improve over time as a determinant of past infection. So, we're waiting with our clinical data, submission to the FDA and determining how much better it is. We're also assessing kind of the pricing, but we're not there yet.

Julie, any idea on just sort of the size of the opportunity for vaccine developers? I have no idea how to size that market?

Sure. So, the way that we're breaking it down, we're looking into three main variables. One is all of the programs by phase, of course, which are – I think we all probably are following a similar list of about 150 or so trials that are out there by phase. We look at the number of patients that are needed for each of those trials and each of those phases, and then we have an estimate for the number of tests per patient that we think would be run on these trials. And that varies, of course, by the phase of the study. And that's kind of – of course, you'll assign a penetration estimate to that calculation of volume.

So, you've alluded to this in your prepared remarks, could you expand a little bit on it. Given what you've learned from your ImmuneCODE initiative, how do you feel about the development of a vaccine targeting the spike protein? Is targeting to spike protein going to elicit enough of an immune response? Or do vaccines need to be targeting other areas of virus as well?

So, we hope so. But certainly, in a natural infection, in terms of cellular immune response, it's a relatively small part of the overall immune response. There's obviously the possibility that if you only put the spike protein in as your antigen, as in a vaccine, you could elicit a much greater response because the immune system doesn't have the opportunity to hit the entire virus, just that one gene. But, probably, I should just say, we hope for the best, but we'll measure it and be able to directly evaluate the difference.

Got it. And I guess on – just an unrelated question. So, can you talk a little bit about your Lyme disease pricing strategy?

So, the pricing opportunity for Lyme or the way we're thinking about it, as we've talked about in the past, we're currently focused on patients in the acute setting and then we'll be expanding into patients who've been previously treated and then on to the chronic population over time. We've done a first round of pricing research to date. And the price range we're still focused on is in the sort of $600 to $800 price range per test. And that's due to a lot of feedback we get in their research that Lyme patients are actually quite expensive to this system. We are going to be launching another round of pricing research as we hone in on the data we're generating from our CV study. And we'll continue to report out as we learn more from that ongoing research.

And I guess, Julie, how much better does your test need to perform in order to get sort of that sort of premium pricing relative to the other serology tests that are on market, acknowledging that they're pretty crappy. But what's sort of the differential that you think you need to show in the trials to command the premium for that nature?

So, the data we're seeing so far is that we're basically about – at least twice as good as the current test. And I think that's really a big difference in what we're also hearing from just the patient advocacy work we're doing and what happens to the patients who are on these sort of diagnostic Odysseys that everybody here from are familiar with. That's I think why we believe we will be able to command a higher price. There are also LDCs out there that patients go to all the time that are even more expensive than that because I just think there's a lot of frustration with the current testing paradigm and the resulting frustration that these – I'll use the same word we're hearing now in the news, these sort of long haulers feel and the payers are quite aware of it.

Next one on the line is by Tycho Peterson from J.P. Morgan.

Maybe just a follow up, Julie, on the T-MAP offering. I know you talked about the pricing structure in 150 or so trials, but can you just give us a sense of the number of projects that you can T-MAP offering now and how material it could be in the back half of the year? We're just trying to kind of get a framework here.

Sure. So, we launched the product last week. It's very new. The great news is that the feedback has been very positive. And we're in advanced discussions with vaccine manufacturers in all phases of development. I think it's probably a little early to tell exactly what to expect over the coming weeks and months, but we're getting very positive feedback. And we believe that immunoSEQ T-MAP is really critical as we all hope for a persistent efficacious vaccine. And this really enables us to be able to study that in conjunction with our pharma partners because it's really the first time you can quantitatively look at T cells. And I think that is definitely resonating.

Okay. And then, on the clinical COVID test, besides clinical utility and share versus serology, can you just talk about how you're going to be bringing that to market? Would you potentially partner with somebody? Do you need to build out a channel? What kind of resources do you need to put behind it?

Sure. That's a great question. So, initially, as a T cell based alternative to serology, we're really going to be starting with the self-pay consumer market, employers and we're actually getting some positive feedback from surveillance programs as well. And we believe that we can handle the capacity for that first tranche of testing commercially with the infrastructure that we have in our lab. So, it would be run much like the way clonoSEQ is today. Having said that, as we continue to generate data and really, hopefully, be able to contribute to answering big questions about immunity, like immunity to the virus itself, post infection or immunity from the vaccine, or if we are able to really bring to market a quantitative way of measuring T cells that might confer preexisting immunity, we are planning for extra capacity with a commercial lab or more than one commercial lab to make sure that there would be the ability to run this test more frequently. And we also are looking into the ability to include our existing RUO kit in the EUA discussions that we're having with the FDA. So, we have a variety of paths that we're exploring, but we would be starting with a standout test much like the way we run clonoSEQ today.

And then, on clonoSEQ, on the FDA approval for CLL for blood first, I think you had talked last quarter about maybe more volume would shift to blood first anyway in the COVID environment. So, has your thinking kind of evolved here that you would put additional resources behind mobile phlebotomy? You mentioned the LabCorp and the home testing offering, but I'm just curious if you're considering kind of accelerating some of that, given the current pandemic.

So, I guess we feel we've definitely put in place the ability to accelerate that by working out partnerships with LabCorp and Phlebotek. So, now there's a variety of convenient and flexible, safer options for patients to obtain blood draws for clonoSEQ. And these partnerships were announced towards the end of July, but we're already processing our first couple of orders from clinicians and patients who have utilized these offerings. So, I think we're also looking at increasing the size of our sales force to reach more community oncology practices because, as we all know, that's where the majority of CLL patients are treated and to make sure that these available blood draw options are present for patients today. I think it's something that's going to be here to stay. So, right now it's an alternative. But in the future, we do believe it will be a real driver for the clonoSEQ business.

We now also, with the FDA clearance, have the ability to market the blood based testing in CLL. So, we've got a whole launch plan around CLL. And in the fall, you'll see we're going to be marketing towards direct to the consumer to the patient as well, which should potentially drive volumes.

And then, last one on ImmuneRACE, when do you think the earliest we could see data from the trials? Thanks.

A variety of the data we've been making public as we go on our ImmuneCODE study with Microsoft. So, a lot of the data is available. Our clinical data in the – we're planning to run a critical validation study using some of those samples in the fourth quarter this year. So, that's when it would be made available. And separately from that, we just had a publication on some of the ImmuneCODE data last week and we'll probably have another publication coming up as well.

Next question comes from Doug Schenkel from Cowen.

I'm just wondering if there's any update on how you are going on with private payers in terms of getting paid on blood based testing for ALL and multiple myeloma. Medicare obviously was a nice addition for you in terms of getting them on board relatively recently. I'm just wondering if that's helped you gain any momentum on the private payer side.

We continue to make progress on the private payer side. As you know, we're more going one by one through the private payers and through the health tech assessment bodies. We do believe that the FDA approval on CLL gives us an opportunity to engage them for coverage on the CLL front as well. Although not required, it's been certainly helpful. But I would say we're making incremental progress on the blood based testing from the private payers. But it's still a pretty small percentage, Dough, in terms of our overall test volumes. It's the larger percentage of CLL, obviously, a smallest percentage of ALL and something that's pretty close to zero in terms of myeloma.

One of the things I think you talked about in your prepared remarks was the momentum you had with new accounts and that playing a key role this quarter for clonoSEQ? I know it's, in the grand scheme of things, still small volume and still early days, but it was good relative to what we were looking for. I'm just curious, was this really a function of just you gaining steam in terms of how you go about detailing? Or do you think that this was some of the carryover and really just the reward of some of the strong efforts you put in pre pandemic?

I really think this is kudos to the clonoSEQ commercial team who truly really understand how to build this market and build relationships with clinicians in this market for that sort of growth that we're starting to see now, exactly as you said. And for example, even during this year with COVID, the team signed over 400, new HCPs. And those HCPs are really starting to use the product a lot faster. So, in 2020, the new HCP has contributed to around 15% of the test volume in Q2. And at this time last year, the new HCPs in 2019 contributed about 8% of the total test volume in the same quarter. So, you're beginning to see the fruits of the labor of the team and the way in which they went about penetration and relationship building, which became even more important in the COVID environment. And there's a lot of trust that's been built between the team and the clinicians, and particularly also in response to the things that we're putting in place to make it easier for patients to continue to know their MRD status, even if it's challenging for them to go into inpatient clinic. So, I think it's really been a great effort led by the team where we continue to add new accounts, new HCPs and faster time to order for the HCPs.

I was just going to say, one other data point that I find relevant, we had some of our major historical [Technical Difficulty] because of the pandemic. So, these numbers were put up despite some of the cancer centers being closed that have traditionally contributed significant amount of the order test volume. You had a significant amount of new accounts over the year, particularly in Q2, during a pretty tough time. So, I think a lot of the efforts that the team had put into place have started to pan out.

And then, maybe just one last one on product pipeline and future milestones. It's great to hear that the first T cell therapy product from Genentech is expected to be ready for IND filing. I think you said in Q1 of next year, which is great news, especially given some concern more broadly is that timelines could slip just given what's going on in the world. Beyond that, I'm just wondering if there's any development in terms of other T cell therapy products from Genentech? I'm sure there are, but I guess what I'm getting at is could we expect any other announceable milestones if not later this year, maybe in 2021, beyond that first IND? Thank you.

Hi, Doug. I'll probably pass to Julie for the milestone comment, but I can talk about the science side. Yeah, we're moving ahead quite rapidly in two directions. So, the product that we're that we've been discussing that we're going to go to IND filing and hopefully clinic in first quarter is our first shared product. We're also working diligently on a second shared product. We're actually building a library. But the second one we're hoping to transition to Genentech actually quite soon. And then, separately, the real goal behind all this is our personalized product where we're going to create an individual therapy for each person by pulling out their T cell receptors and then putting them back in with a transplant. And that requires a build out of facilities and both Genentech and Adaptive are building out the required facilities with the goal of having those up and running in sort of early 2021. So, first quarter, as well. And then throughout next year, working on getting that workflow and pipeline down and hopefully moving at the end of next year towards a filing.

In terms of milestone payments, we expect milestone payments upon IND acceptance and upon first in humans for each product. We haven't disclosed the amounts of those milestones, but they are – the first in human follows shortly from acceptance. And obviously, Genentech certainly controls the timing for the IND filings.

Next one on the queue is Salveen Richter from Goldman Sachs.

So, just two for me. One, with regard to the head to head study with your T cell based diagnostic test, could you go further here into the data and how confident you were in this and with the comparative arm with regard to the serology tests? And then secondly, with regard to the TCR program with Genentech, when will you disclose the first target here?

This is Harlan. I'll start with the first question, which is on our T cell based tests that would be a comparator to the serology test. We actually feel quite good about the data and we did a real world study. And we focused on patients where they were in the spot where the serology test is valid, meaning after – these were convalescent patients at least 14 days past diagnosis. And the majority of the subset, I think six or seven of the patients of the Adaptive test showed negative. It was showing negative by serology. So, we had a massive overlap between the two and the big delta between them was a set of patients that Adaptive was able to find as positive and serology was not. So, I think we feel quite good about the data. Obviously, it's not a massive study yet and our clinical validation study will be – that we're going to go for EUA will be bigger. This was a test to just make sure that we really, in a fair way, understood the data and understood our expected results. And the great part is that that we're also – our test continues to get better over time. That's where we're at right now. And so, that's why we felt good about presenting it where we are. We don't think it's going to get worse relatively speaking because there's a very large number of T cell receptors in the entire population that are specific for SARS-CoV-2 and we've only uncovered a set of a few thousand so far. And every one we uncover makes our test better. So, we're moving in a very good direction.

Your second question was about when we would know the target. And the first target will be disclosed at the time of the IND filing by Genentech, which is expected again in the first quarter. We have disclosures against the solid tumor target.

Next one on the queue is Brian Weinstein from William Blair.

Curious if all the work in COVID-19 is helping advance discussions with partners or potential partners on anything beyond COVID-19 if you guys are really able to showcase your capabilities, which obviously would be more important to longer term. So, anything on that?

That's a great question, Brian. And the answer is absolutely. We've been in discussions about kind of mapping T cell receptors versus antigen for multiple disease states. And I think the fact that we could do this quickly when COVID came up, release the data in a publicly available database and show our capabilities has catalyzed some additional discussions that we've been – actually ongoing with several partners.

I'm just going to add something interesting. As you know, the initial proof of concepts for our ability to map receptors to antigens was in CMV. But now that we've actually offered T-MAP, some of our academic groups that we work with have actually started to ask – they're like, 'oh, now, I really understand it, can you give me the information for CMV also?' So, it's interesting that it's actually helped to sort of clarify what is possible from our platform disease by disease. And I think it's actually putting into context some of what we've sort of explained in past and it's coming back up for other disease states we've done and new disease states that we can do.

And then, as it relates to the work with Amgen, you guys give a little bit of an update there, but can you just talk about your confidence of your ability to kind of find, as you referred to, called the MJ of neutralizing antibodies here and then Amgen's willingness to commercialize. How you're seeing that market sort of play out?

I think we're feeling pretty confident. We've been going at this quite broadly and moving through a very large number of potential antibodies and screening from hundreds of people now. And the data is looking quite promising. There's some other groups that are ahead of us and seem to be doing quite well, the Regenerons of the world, for example. But we're going after quite different targets, they're all pretty focused on the spike protein. And so, if we need more broad targets than the initial group is finding, which we expect that the efficacy is going to be hopefully reasonable from some of these first movers, but probably, as you can imagine, no one's perfect the first time. So, we think we would have a lot to add. As for Amgen, we're going to present them our best case and they have a lot of factors to consider. But they're pretty open to and excited about the concept. And so, hopefully, the timing's right, we're on schedule as far as our initial plans with them, and so all things are moving well. A lot of effort going on in our various labs. So, we'll update you as we move forward both our own progress as well as discussions with Amgen.

And then, last one for me, if I could sneak one in here, is just to confirm that the pricing and the reimbursement on blood versus bone marrow is really no different for CLL. Could you guys talk about the timing for ALL and multiple myeloma? If you did, I think I missed it. If you wouldn't mind repeating it, I'd appreciate it.

Chad, you want to take the pricing question and then I'll answer the…

The answer to the pricing question is, exactly the same for blood or bone marrow. And actually, to a question earlier, some of the private payers don't want to specify sample type either, but the pricing is the same. The second, ALL and MM and blood. Julie, do you want to cover, ALL and multiple myeloma?

Sure. so, the ALL work, the data has been generated, everything that's required for a filing to the FDA. And we are going to be beginning those conversations now that CLL is winding down. So, that'll start up soon, those discussions with the FDA.

Next one on the queue is David Westenberg from Guggenheim Securities.

Hi. Thanks for taking the question. And thanks for all the work you're doing with COVID. So, I guess, my first one is probably for Julie, but it might be for Chad. In terms of clonoSEQ, I would think the temptation is to order it more frequently as more information is obviously better than less information. So, if you can maybe talk about the behavior of the early adopters, the 1% maybe of your customers that order the most frequency, what is the frequency in which they order? And I get that not all patient is the same, but I'm just trying to get a sense of – if you could test all the time, how frequently would you test?

Sure, I'll take that. If you're truly talking about the power users, depending on the indication, but in ALL, in multiple myeloma so far, we have clinicians that are testing new patients on a monthly basis. Again, this is a smaller subset of what we'll call the power users that are continually monitoring a patient's disease burden over time, looking for spikes back up and to provide clinical decision making based on that information.

And then, in terms of – I think Brian might have been asking a similar kind of question, but in terms of Amgen and the timing for them to get a product once you give them the antibody, so I'm not kind of familiar with how long the kind of the – it would take that – so do you have a kind of a good estimate on that.

We're working on a lot to just specify exactly, but I can just tell you it's a pretty short fuse by design and construction that if we have something, it's either take it or move on and allow us the optionality to another partner. I think both parties recognize that the external landscape is moving quickly here. So, we want this kind of flexibility to [Technical Difficulty]. Just in Amgen's, since they would control that timeline, what Amgen – their words are months, not years. So, they would be motivated to move fast. Obviously, there's no – this world is not [ph] moving very fast.

On immunoSEQ Dx, you've talked about you could run so many different studies in parallel. I think you've said six, seven, eight projects at a time. Now, you have a building, you have a lot more – you're building a building, you have a lot more cash. In 2021, do you maybe run more programs than that at once? And kind of help us understand how fast these clinical timelines could go.

Sure. That's a great way of phrasing that question. That's absolutely one of the reasons for the capital raise. We've really honed our R&D funnel into five stages. And we sort of move – we're working on about four to five indications in each of the five stages now, and so we're really, really learning how to do this, how long it takes, what it really requires, how to hone the TCR signatures and move the diseases through that funnel. So, we're really focused on this. And that, as you mentioned, is one of the main reasons for the raise.

And there are no further question on the queue. You may continue. Ladies and gentlemen, this concludes today's conference call. You may now disconnect.