Adaptive Biotechnologies Corporation (ADPT) Earnings Call Transcript & Summary

August 11, 2020

NASDAQ US Health Care Life Sciences Tools and Services conference_presentation 45 min

Earnings Call Speaker Segments

Daniel Brennan

analyst
#1

Good afternoon. Welcome to another session here, day 1 of the UBS Genomics 2.0 Medtech Summit -- Medtech Innovations Summit, excuse me. Really pleased to be joined with me here at 2:00 session with Chad Robins, CEO, Co-Founder of Adaptive Biotechnologies. Chad has been amazing through this conference. I met Chad, I don't know, 6 or 7 years ago when John was hosting this conference, when he was at Macquarie. And since then I've followed the company. Obviously done remarkably well quarter last night, which we'll get into. And Chad has been super impactful as a -- kind of helped orchestrate this conference, making a lot of introductions. So beyond the scenes, he's been absolutely fantastic. So Chad, thank you for all your help and support on the conference, and welcome.

Chad Robins

executive
#2

Thanks, Dan. It's great to be here. Appreciate it.

Daniel Brennan

analyst
#3

I'm just going to bend down for one second. Great. So I thought we can kick off. First, congrats on the quarter. I know you came in ahead of the preannounced numbers at the time of the secondary. I thought we could start just on the COVID products. I know there's a lot of questions last night, so hopefully I'll add a little bit of value beyond what was already discussed. But maybe we could start with the immunoSEQ T-MAP, the research product. I think Tycho may have asked a question last night on the call about this, but I wanted to maybe go a little deeper. So there's over 100 trials in -- I think there's over 100 preclinical trials, 40, 50 in human right now. And my numbers could be off by a factor. So how do we think about the revenue and penetration opportunity for this product for Adaptive? I know it just launched early last week. How do we think about that? And kind of what's been the feedback so far?

Chad Robins

executive
#4

Yes. Well, first of all, Dan, as you mentioned, we did just launch this product based on data that we just published, but we're already in active discussions with manufacturers across all phases of development, including those in Phase III. And fortunately, and as you know, we have preexisting relationships with many of these companies already. So the discussions, I would say, given our credibility, given the fact that we have agreements in place already on the research side, they're moving very quickly, and the feedback so far has been extremely positive. In some senses, not -- obviously, not in COVID because it didn't exist yet, but in many disease states, our research partners have been asking for the last 10 years, "Hey, you can sequence a receptor, but can you tell me the antigens that it binds to?" And so far, we developed those capabilities in 2018, but we haven't released those. And this is the first time we're really releasing the ability to annotate what the receptors are binding to. So it's -- the discussions have been extremely positive.

Daniel Brennan

analyst
#5

Got it. So not only having maybe a tremendous impact on the efficacy success of some of these trials but also ideally, in a couple of quarters or so, this could begin early and show up maybe as a bit of a needle mover, or you think really it might not be big enough to move the needle but it'd certainly be additive.

Chad Robins

executive
#6

Well, we certainly hope so. I mean -- and we really look at a bottoms-up approach to building the model. As you mentioned, just from a numbers standpoint, there's about 115 vaccines in development. We break those up by trials. We break a lot by the number of the patients per trial and the number of sampling for each patient on each trial and just start building the model. And then we attach a kind of penetration rate. And obviously, we're going to start that penetration rate at low and then build that up over time. Just in terms of pricing, it's just -- it's an extension of our fee-for-service offering for immunoSEQ, which is broken down into a per sample price and a technology access fee for the data analysis.

Daniel Brennan

analyst
#7

Okay. Excellent. So maybe just going over to the diagnostic opportunity with immunoSEQ Dx. So on serology, how long will it take to produce meaningful data? And then related to that, I know you spoke really -- I think Harlan spoke last night just about the efficacy, some of the early, early data that you -- or I don't know how early it is but some of the data that you've gotten. You have again some really large competitors with low cost and a large installed base. So maybe just talk through about when we'll be able to see meaningful data? And how do you really compete with these big entrenched players?

Chad Robins

executive
#8

Yes. So first of all, we announced yesterday in the earnings call that we do have meaningful data already in terms of a head-to-head study comparing the T-cell-based test versus the 2 leading serology tests out there. And we're already comparing favorably, meaning at a -- at the same specificity level, we're already more sensitive. And the difference is we're just going to get more sensitive over time because the classifier T-cell receptor signature continues to improve with more data. And with that data, we're currently in discussions with the FDA on the AB and CB protocols that were -- are needed for the emergency use authorization submission. And we're moving really quickly. And so data will be released in terms of kind of publication on that. And we expect to be able to launch a test kind of in the fall. With respect to the second part of your question with -- yes, it's a crowded space. Really, first of all, there's really 2 types of testing that are allowed under the EUA. There's 2 EUAs. One is kind of upfront diagnosis of PCR-based testing, and the second is kind of serology-based testing. What we're seeing on the serology-based testing front, we recognize that it's a sequencing-based test. It will have a higher price point. And we recognize that it -- that there is a crowded space, but this is the first T-cell-based test, and it's going to prove to be more sensitive in a real-world setting than the current kind of antibody serology testing. It's really -- and it's only the beginning of what the T-cell test diagnostic might tell us about the immune response. Really, the holy grail is to be able to confer immunity, post-infection immunity, to be able to tell you whether there's efficacy of a vaccine in a diagnostic setting, whether there's a durable response of a vaccine or whether you need to get a booster. So we already had these conversations with the FDA about continuing to collect real-world data and evidence with the clinical correlates to be able to determine these really key questions. So the determinant past infection, these are really our first utility and entry point, which we'll take through the EUA, but we'll continue to develop data to get to those really important questions about immunity that will allow for kind of true opening of the society even with a vaccine.

Daniel Brennan

analyst
#9

Interesting, interesting. Okay. That sounds great, Chad. And then in terms of -- just on the diagnostic front, I guess. To, I think, someone's question last night, I think you said by Q4 you're going to have some data on the ImmuneRACE. And similarly, could you just lay out what would be the kind of key differentiator there again? Because you're kind of going into a market where there's a lot of entrenched competitors and as a sequencing-based test. We just did the meeting with Sri, and he couldn't then more construct it broadly on the need for more capacity, and we just need more testing that's out there. So certainly, he's a good advocate.

Chad Robins

executive
#10

Yes. Sure. So let me just make a couple of points on this. ImmuneRACE is -- it's part of our ImmuneCODE program. And so ImmuneRACE is our own IRB-sponsored study. And along with the rest of the samples that we're collecting from cohorts around the world, there's a total of kind of 4,500 samples that are going into this ImmuneCODE program. And the head-to-head serology data that we shared yesterday is on 100 convalescent patients from our ImmuneRACE study. So when you're mentioning kind of Q4, we're talking about the launch of -- the anticipated launch of a product, which will happen in the fall. But in terms of data on that head-to-head in serology, we will be kind of releasing that and publishing that prior to Q4. In terms of kind of the initial market, as you mentioned, we're going after kind of the consumer market, the employer market and the surveillance market. So a lot of what Sri is working on, and I'm on a weekly kind of call-on policy and thought leadership around COVID, both from a diagnostics and a therapeutic perspective, we're not going to be a point-of-care diagnostic testing. As I mentioned, kind of our entry point is going to be for a better determinant initially of whether you've had to defect the infection, and we will be able to tell early and all throughout that patient journey. Even at longer time points, we're seeing that the TCR data's holding up really well. So let's give a practical example, Dan. If you had a pretty bad kind of cold or flu in kind of late March and want to say, "Did I have COVID?" You could take our test to determine whether -- a T-cell test to determine whether you had it. Again, the point here is that what we're going for is to say, okay, well, does that then mean that you have immunity of the virus? We're not there yet, but we are collecting the data to answer some of those questions.

Daniel Brennan

analyst
#11

Got it. Okay. All right. Great. So maybe we'll shift over to clonoSEQ. Obviously, I think one of the highlights from last night -- or kind of one of the interesting takeaways I thought was to one of the analyst questions, and I think Julie answered it in terms of the growth from -- the impact from new doctors who are -- or new -- I guess new HCPs that were prescribing, I think, drove 15% of volume of HCP. I don't know if that's center or doctor, you have to correct me on that. But I think that was up from 8% of volume from last year. So maybe just speak a little bit to how that came about. Like why are you seeing such an uplift this year from that? Is it just a cumulative volume number in terms of how many you're adding right now? Or is it a utilization issue? Maybe speak a little bit to that kind of impact that you saw year-to-date.

Chad Robins

executive
#12

Yes. A couple of comments on that. One is we've been laying the groundwork for clinical adoption, both by peer-to-peer programs, our field force being out there, publications, our conference work, webinars, all of the kind of groundwork that needs to be laid for kind of market adoption of a new diagnostic product in terms of the publications, et cetera. So that work, along with increasing the size of our field force, is starting to pay off. For HCP, over 417 new HCPs have been added year-to-date, including greater than 125 new HCPs added in the second quarter. And the other point is the new health care providers are starting to use a product a lot faster. And we're -- this is even in the face of doing virtual onboarding. For example, the newer HCPs in 2020 contributed approximately 15% of the test volume in Q2. And this time last year, the new 2019 HCPs contributed only 8% of the test volume in the same quarter. So these are really, really good trends. And frankly, I'd be super interested to know, I mean I know a lot of us would be, in a lot of our businesses what the trajectory would have been without COVID. But some of it is just you put in all the work. And at some point, with you showing utility and adoption, it starts to take hold, and we're starting to see that.

Daniel Brennan

analyst
#13

So obviously, the shift in the blood is critical, and you guys have talked a lot about it. And I know you've got now the FDA approval. So -- and you -- just maybe a high level, like how does someone think about what it means for adoption and uptake? Like we spoke to a couple of oncologists. We're going to do this MRD panel tomorrow. And I think they've been really constructive about what blood means. But how would you just kind of give a high-level view about the importance of blood and kind of the accelerated pace of maybe adoption?

Chad Robins

executive
#14

Yes. I mean, medium and longer term, it's just critically important because it's just so much more convenient for a patient to get a blood draw than it is for them to get a bone marrow biopsy. And what that ultimately says, as the utility across kind of the patient care continuum of when you use the test, as that continues to increase, that's going to work in concert with blood-based testing. Meaning if you can do a less invasive test, a doctor's going to be much more willing to test a patient on a much more frequent basis. However, I want to temper that enthusiasm just a little bit in the sense that doctors need to be convinced. And again, we published on this in a variety of different kind of disease indications. But always changing clinical behavior and really the practice and workflows of a clinician are -- can be a challenge. For -- just taking for CLL, we expect more of an uptake to take root in 2021 as we -- as they start to materialize from all the planning we're doing around the CLL launch campaign. And for the first time, too, in the fall of this year, we're going to be launching really a direct-to-patient marketing campaign. It will be largely based on digital and social, and we're going to kind of monitor very closely and look at metrics of what's working and successful and deploy additional capital in the areas that are successful. And over time, we'll build up to kind of more of a traditional media and TV as time kind of -- as we start to see the success of the campaign.

Daniel Brennan

analyst
#15

And in terms of -- I know this came up, I don't think recently, but I forgot the numbers on salespeople. So I know you've definitely expanded the sales force pretty significantly maybe over the past year, 1.5 years, I believe. But maybe could you just remind me kind of what's your sales force today that are selling clonoSEQ? How do you think about the ROI on adding more salespeople? Given the momentum in the business, I would think there's a really high ROI on that. But just kind of walk us through kind of the numbers and kind of how you think about further addition from here.

Chad Robins

executive
#16

Yes. As you know, we've doubled the size of our sales force in this year, and we continue -- I'm sorry, at the end of last year. And so we're -- through the first quarter of this year, excuse me. And we continue to -- we're looking at adding key reps and demand-generation reps where appropriate. And we're just starting to put in place that tracking the ROI per rep because all the training modules have been put in place right now, and we've got kind of a much better kind of sense. What is interesting, though, Dan, is we're looking at models. Right now, we've got kind of territory-based reps. But as we've gone to a more virtual -- not more -- a virtual world right now because really, our reps aren't seeing clinicians. They're doing everything kind of over webinar, over the phone, as I mentioned, even onboarding accounts. So talking about kind of where reps have the best relationships, we're really rethinking and strategizing the best way to utilize our reps and how to segment our reps between kind of market development and then kind of demand generation once we're in an account, starting to work that account. So we're looking to kind of incrementally bring on reps towards the end of the year as we continue to monitor the COVID environment. But we certainly want to see kind of these investments, and we're seeing them start to pay off.

Daniel Brennan

analyst
#17

And in terms of like coverage, I know you ended last year with, I think, 175 million lives. Have you guided -- or have you given color for where you think that goes in terms of whether it be this year or kind of in the next year?

Chad Robins

executive
#18

Yes. We've set out a target of 220 million lives -- covered lives by the end of this year.

Daniel Brennan

analyst
#19

Got it. Okay. Talk about the competitive landscape. I mean in kind of MRD and blood cancer, I mean, you're the only really game in town today. How do you think about that kind of market evolving over the next, call it, 3-plus years?

Chad Robins

executive
#20

Yes. I mean I think there's a couple of things. I mean one is we're the only FDA-cleared MRD test. Second is we are the -- we've been integrated into the clinical trials as surrogate end points and moving, in some cases, to primary end points in clinical trials. There is some competition from next-generation flow. It's, frankly, in my opinion, going from like an analog to a digital camera with next-generation sequencing. And there's some competition from -- in next gen such as Invivoscribe who offers a distributed research product for clonality that some labs are turning into a test for MRD. But this is an area where we clearly expect to take the lion's share of the market opportunity.

Daniel Brennan

analyst
#21

Okay. And when you run into doctors that aren't adopting clonoSEQ, is it a function of they're just tied to the old way of doing and they just haven't seen enough data? Are there any -- what are the key sticking points that your salespeople run into or even you run into when you go do sales calls about doctors that are just kind of haven't adopted yet?

Chad Robins

executive
#22

Yes. I mean, look, some of it -- and this is the case in diagnostics in general. I mean there's certainly a hurdle -- a blocking-and-tackling hurdle in terms of getting integrated into the workflow and just getting that inertia in saying, "Hey, we're going to do things differently." But the biggest hurdle always is proving the clinical significance that knowing a patient's MRD status is actually going to guide treatment decisions. And as more data continues to emerge about the specific use cases of where doctors are specifically using the information to make treatment decisions on the case -- on each one of their patients, the cases are becoming more and more obvious with the aggregation of data. It just makes sense. I was down at Children's Hospital of L.A. And a clinician -- one of the clinicians was telling a funny story about in the 1800s that clinicians were saying -- doctors were saying, it was cheating to use a thermometer, that they didn't need a thermometer to tell them about a patient's status. They could just look at or feel a patient, and it was just unnecessary. So you deal with some of that in terms of doctors being set in their way. That being said, we're starting to see a lot of the peer-to-peer education programs that we're doing and a lot of the publishing, a lot of the kind of changing of guidelines. A lot of this is just taking root now in terms of how it's affecting adoption patterns.

Daniel Brennan

analyst
#23

Okay. And then I know NHL you've given some color on, but I don't know if you've given kind of any timing on clonoSEQ there. So maybe just kind of refresh my memory about how we think about NHL.

Chad Robins

executive
#24

Yes. We're not yet giving timing, but we're already running several investigator-sponsored trials and pharma trials using clonoSEQ in NHL. And the data, we'll continue to develop in NHL like it has for the other indications. It's behind blood-based testing for ALL and then multi myeloma readout next year in the blood. And then from there, some of the NHL data will start to read out. We'll see what it says. And hopefully, we're able to take -- tackle that large basket of diseases, which is -- adds significantly to our TAM.

Daniel Brennan

analyst
#25

Okay. Good. So maybe we could switch over to immunoSEQ. So how many -- this might be -- I didn't see it on your website, so it might be there, Chad. How many pharma partners are you working with today? And kind of how has that changed over the last, like, say, 12 months?

Chad Robins

executive
#26

Yes. We're working with over 40 pharma partners in 190 trials. One of the things -- as you know, and we mentioned in earnings, revenues were slightly down. And in life sciences research business, in the academic setting, people aren't back in labs. And in pharma, you need CROs to be open and people to be at pharma companies to ship samples. But that being said, kind of new bookings increased 4x in this quarter versus last year. So really, in terms of kind of the long-term viability, the interest of incorporating immunosequencing into research trials is -- we're excited by that trajectory. And these -- it's also kind of worth noting that these partnerships contribute to both our sequencing revenue as part of the life science research business, but also, they contribute to the development revenue. We've got a big backlog of development revenue via our regulatory milestones, which are kind of sitting out there and are associated with really the, I'll call, bespoke diagnostic deals outside of the regular fee-for-service projects. And there's about $270 million of possible milestones payments that are available to us over the next couple of years. Example of that, as I mentioned earlier, as we're incorporated into kind of MRD trials as different end points, as those therapies are approved both in the United States and in Europe, those milestones then we can start to draw down from that $270 million that are sitting out there on the balance sheet.

Daniel Brennan

analyst
#27

Got it. And I'm sorry, you said you're working with 40 pharmas?

Chad Robins

executive
#28

Yes, over 40 partners in over 190 trials.

Daniel Brennan

analyst
#29

So kind of what is your TAM on the partners? Is it -- I don't know, is it 80? Is it 100? Is it 500? Like how many potential -- I mean how many potential pharma partners are out there? I mean you were -- like when you think about the big ones, are you working with kind of all the big ones? Or is there still a meaningful…

Chad Robins

executive
#30

Yes. Yes. I mean, yes, we are working with all the big ones or -- I'm always hesitant to say all, but most all of the big pharma, if not all, but in various context. As you know, we actually started primarily because we -- Julie made a hire who had a lot of relationships in cancer, and our technology was developing in a world of cancer immunotherapy. So it was kind of a natural place to apply an immune medicine platform to the cancers, to the oncology space. So a lot of -- and at the same time, we had our MRD kind of product out there that was FDA approved. So that started getting incorporated. Now what you're seeing is we're starting to really expand beyond cancer. We've got a concerted effort to say, "Look, whatever disease state you're studying, whether it be autoimmune disorders, infectious diseases, anything that's immune-mediated, now we have a much better tool to be able to apply towards that early-stage research or on your clinical trial." And so that's kind of where -- how the business, the life science research business is expanding, even though -- we think it's a nice business. It's got about $1 billion total addressable market opportunity, of which $850 million is in really the biopharma space and $150 million we've calculated in the -- really in the academic space.

Daniel Brennan

analyst
#31

Okay. Great. Maybe discuss the Genentech trial where MRD is a primary end point. Like what's the significance of this for MRD and clonoSEQ?

Chad Robins

executive
#32

It's incredibly significant because it's really the first -- this is CLL for VENCLEXTA. This is the first trial where clonoSEQ is being delineated as a primary end point. And so what that means is the FDA, based on the data of MRD, whether that cohort is -- you can stop the trial if the drug gets that cohort or that patient population, that arm, into an MRD-negative status. That means, respectively, that the therapy was effective and they can get an earlier approval on the drug. Why that's so important is because if a pharma company can shave even months, but let's say a month, months or potentially years of waiting for data on kind of overall survival or even -- this is incredibly important as kind of one of the new metrics by the agency to look at therapy approvals.

Daniel Brennan

analyst
#33

And like would you expect, like to the extent more trials would adopt that primary MRD, that just further solidifies and entrenches Adaptive and clonoSEQ within the framework of kind of blood cancers, I guess, right?

Chad Robins

executive
#34

Absolutely. This goes back to a competitive question, right? If we're -- if you're able to use clonoSEQ to get a drug approved faster, that will just -- we're already -- as you know, we're already working with many of the pharma companies who are -- biotech and pharma companies who are developing hematologic malignancy drugs for lymphoproliferative disorders, but this will -- I can't imagine, well, doing a trial without incorporating MRD, if it's going to be a primary end point. That discussion on certain indications is further advanced than others, I'll say it that way.

Daniel Brennan

analyst
#35

Okay. So maybe we could shift over -- so immunoSEQ Dx, the Lyme opportunity sounds exciting. I think you gave some more color last night. I think you discussed maybe some of the false negative rates of the serology tests that are out there. Like I think Julie or Harlan mentioned 60% to 70%. Maybe can you just kind of set the table a little bit for kind of a trial that you're running right now on Lyme and kind of what the clinical end point is and how you think the numbers really shake out for what you could deliver versus what the standard of care is today?

Chad Robins

executive
#36

Sure. Just in terms of timing, we expect to have results from the ImmuneSENSE Lyme study towards the end of the year. We file with the FDA, go through that process and hopefully launch towards the end of 2021. We've enrolled the study with IQVIA, and we expect to demonstrate the sensitivity and specificity of our test and development in patients with signs and symptoms of suspected Lyme disease. So this study comparison will compare our T-cell-based diagnostic approach, again, to the standard of care, which is serology, which, again, isn't very, very sensitive and has not only a high false positive and a high false negative rate. We're going to be collecting up to 4 longitudinal samples for a year, a year longer, to be able to answer questions about patients also that have recurring Lyme symptoms after the standard antibiotic treatment is administered. And then just in terms of -- do you also want to hear about kind of the go-to-market strategy?

Daniel Brennan

analyst
#37

Yes, yes. No, I mean it's much bigger market than I guess I haven't been on top of, but I mean 3 million patients…

Chad Robins

executive
#38

Yes. It is actually a pretty significant market. There's 3.4 million tests performed each year in the United States, and about 1 million of those are in the acute setting. And of the 1 million that are in the acute setting, there's 600,000 patients who are what we call unsure if they have Lyme. For example, they don't have the traditional bull's eye rash that everyone knows is indicative of Lyme. And so the initial focus is to be able to kind of really target that segment of the unsure population, which is 600,000 people, since the standard -- as you mentioned, kind of the standard serology test has so many false negative because your antibody or your sero conversion, your antibodies wind up coming up too late to be able to tell. So often, you go with a set of symptoms and say you don't have Lyme when you actually do. The next step is to move to patients who have been treated unsuccessfully with traditional antibiotics, but yet they're still experiencing symptoms. And this will add on about another 200,000 patients each year. And then kind of longer term, we're going to go after this chronic population who were never tested for Lyme, and they're going through this massive diagnostic odyssey trying to solve for what it is they have. And it's just really tough. You see a lot of -- if you go on kind of some of the kind of Facebook groups online, there's a whole core of these patients who have chronic Lyme or think they have chronic Lyme. And in terms of pricing, kind of we're still engaged in the pricing research, but the cost of Lyme to the system is so significant that based on some of our pricing research, our work with providers, with payers, we're targeting that this is going to be a higher-end test that could potentially command between $600 and $800 a test.

Daniel Brennan

analyst
#39

And in terms of the go-to-market strategy there, like how many salespeople are you going to need? Like is this -- I forget. I mean are you touching any of these infectious -- I guess these infectious disease doctors? Or is it any PCPs to do with Lyme disease? I'm not sure.

Chad Robins

executive
#40

Yes. We're in the process of developing that strategy right now. I think it's too early to determine kind of the number of reps segmentation. All that is certainly part of the exercise that's under evaluation and in study right now, but it's too early to talk about talk about that. I will say that, clearly, there's going to be a target on not only infectious disease doctors, but we're at least assessing -- we are assessing the primary care because a lot of times that's the first stop and kind of the odyssey is, "Hey, I don't feel well. I'm going to go to the primary care." So at least an awareness campaign to make sure that the primary care physician is aware the test would be something that we're -- we think is important.

Daniel Brennan

analyst
#41

And kind of how meaningfully different -- maybe one more. How meaningfully like improved would the performance be, you think, of your test? And what are you seeing in some of the data now in terms of -- that would then dictate maybe the pace of uptake if it's a dramatically better test and ensures you that you should likely see a fairly high switch rate over to your test. But I'm…

Chad Robins

executive
#42

Yes. We anticipate -- and based on the data that we've seen already that it's going to be a dramatic improvement over, what I'll call, the challenging current testing paradigm for Lyme. And the neat thing about this is -- just like I mentioned for COVID, is really this is a self-improving diagnostic. So the more data that we accrue, the better the sensitivity of the test gets because we're able to continue to hone that TCR signature and classifier over time.

Daniel Brennan

analyst
#43

Got it. And I know this question's come up -- I mean I've read through and talking with you and Harlan, but it's like how much does the proof-of-concept on Lyme validate what you're doing with the whole Microsoft partnership such that the next target that you're going to announce, like how much confidence could you insinuate from the success on Lyme towards the ability for the next one? So maybe just speak a little bit to that. I guess you're planning to announce your second target by year-end. So how does -- how can an investor get some confidence around what the utility and potential efficacy of that will be based upon, so far, Lyme?

Chad Robins

executive
#44

Right. Actually, Dan, given our quick pivot to the SARS-CoV-2 and in the coronavirus pandemic, we actually were able to accelerate the launch of our first immunoSEQ Dx product and anticipate launching it this year. So in terms of the next clinical product or signal, that was accelerated by immunoSEQ Dx COVID. Obviously, we might be renaming that. And so it also allowed us to put in place a lot of the infrastructure and accelerate some of those investments and really the algorithmic approach in infectious disease. So we're really excited about that -- I mean -- sorry, I mean, that's a tough way to talk about it in the context of the pandemic. But in terms of the proof-of-concept of the immunoSEQ Dx platform, I think that COVID did for the platform. And also, if you think about kind of the general importance of understanding and characterizing immune response to any disease, it was accelerated in a way that we never could have done on our own, right? I mean you have your mothers, grandmothers, brothers, sisters all talking about antibodies and now, in the last kind of month, T-cell receptor response to disease. And we've, a couple of years ago, started building that infrastructure and now, in literally a matter of 4 or 5 months now, have the most comprehensive map of T-cell receptors to any disease that's ever been done before. So I think in terms of proof-of-concept, yes, Lyme is super exciting and as a product launch in late -- expected late 2021, but the product launch of COVID Dx at the end of this year, I think, will be great in terms of proof of concept for immunoSEQ Dx that we can map the T-cell receptors, the antigens that are specific for disease and then use that map to diagnose disease.

Daniel Brennan

analyst
#45

Great. And maybe just one more because I think someone might have asked this question last night on the call, but it was late. I was -- from the work that you've done so far, do you have a view towards the durability of the response and how long that lasts? Or we just don't know right now in terms of these neutralizing antibodies and how long they actually last and how long immunity could be conferred post someone being affected?

Chad Robins

executive
#46

Yes. We're working on those clinical correlates. As I mentioned, kind of the strategy of getting the EUA approved to first determine who's had the infection and at the same time continue to collect kind of that real-world data and the clinical correlates to be able to answer those questions of kind of post-infection immunity and immunity to a vaccine are things that will come out in conjunction not only with our diagnostic but being on, knock on wood, several of these vaccine trials that should be able to answer those questions over time.

Daniel Brennan

analyst
#47

Great. Okay. Excellent. So yes, so maybe switching over to therapeutics, obviously. I think you announced last night, what, it's going to be the first quarter of '21 is when the IND will be filed with Genentech. Is that right?

Chad Robins

executive
#48

Yes, that's correct. We delivered our data package in Genentech and moved to the next stage in their process and expect the -- then to file the IND in the first quarter of 2021.

Daniel Brennan

analyst
#49

And that's -- will we -- what will we learn between then and now?

Chad Robins

executive
#50

There's probably not a -- unfortunately, we're not allowed to disclose the target that we're going after until Genentech files the -- they'll do so, obviously, at the same time that they file the IND. But after that, the kind of first in humans is anticipated to come relatively closely on the heels of the IND approval in the first half of 2021. I do think it's worth kind of mentioning that Genentech is in control of all our regulatory discussions. It is worth mentioning because we have alluded to this that the target is a solid tumor-based target.

Daniel Brennan

analyst
#51

Got it. Okay. Right. So in terms of -- I don't know the model on the company, so I don't know how long out in terms of what you've guided people on kind of milestones and things of that nature. But is there any way to think through, eventually, if that turns out to be a clinical success, is that 2022, '23, '24? We'd have to wait until kind of next year to kind of figure that out.

Chad Robins

executive
#52

Yes. We haven't disclosed yet. I mean I think we'll know a lot more after kind of when we file and lay out the clinical path to commercialization. I think it is worth noting, though, that we are advancing as we've alluded to or specified on the second shared target. We have a joint steering committee that's -- and they're currently reviewing our T-cell receptor data on several candidates against a few of kind of the leading antigen targets that they've picked. And if one of them meets the threshold for the collaboration that we set out by the joint steering committee, it's certainly likely to move forward on the second shared product as well. I think it's probably too soon to specify on timing on that. But that is one area that I would say you may have more information on in terms of kind of news flow prior to Q1 of 2021 in terms of something to track.

Daniel Brennan

analyst
#53

Excellent. And have you said how many other companies you're working with in this space, how many other pharma companies you're working with? And kind of have you given any guidance around which you might see something coming out from another partnership besides Genentech?

Chad Robins

executive
#54

Well, in terms of this kind of deal and in true drug discovery where we've really -- we've got 2 programs, one on the T-cell receptor side in oncology. And as you also know, we have one on the antibody side or the B-cell receptor side that Amgen has an option to license for commercialization, and that's with respect to a neutralizing antibody for COVID-19.

Daniel Brennan

analyst
#55

But on the therapeutics side, I mean, you're not exclusively locked into Genentech if you wanted to work with other companies.

Chad Robins

executive
#56

No. I mean there -- sure, Dan. There are other areas that we could deploy our platform, both cell therapy outside of cancer and other modalities within cancer or outside of cancer with -- the only thing we're exclusive on with Genentech is cell therapy cancer. So even the vaccine space is open to us. And as you can imagine, there's a lot of potential areas where we could deploy our platform in drug or vaccine discovery. We're trying to be judicious and thoughtful about how we approach these partnerships to make sure that we're -- kind of can be successful and targeted. Over time, of course, we will deploy our platform in new ways. As a matter of fact, I mean, just a great example of that. And as we've always -- we've talked about since the IPO about being an open-ended growth story. And when the time is right and the opportunity is right, we would jump into other therapeutic areas to deploy our immune medicine platform. We actually did just that with COVID-19. We essentially took technology that we've been working on for the last few years, got it up and running in really a few short months and had synthesized over 1,000 antibodies that are now moving forward for characterization and neutralization assays for SARS-CoV-2. So this is an area where we're moving very quickly. And frankly, we -- let's be honest, we fully recognize that we're not going to be first to market, we're not, on a neutralizing antibody. You got Regeneron. You've got Lilly. But we do think that we have a differentiated approach. But even if we're not successful in this area, we do believe that we can deploy our antibody platform in other areas as well. This is the capability that we've developed, and we've developed kind of relatively rapidly that now can be used across potentially many other disease indications. But even on -- unfortunately, our hypothesis on COVID-19 is that -- and what we're seeing from our data that we just published is everyone's going after the spike protein. And that's a logical target. But what we're seeing is that T-cell receptors that are specific to 11 other parts of the virus, that may need to be considered. And we are looking at neutralizing antibodies that do consider that, and that's a unique and differentiated approach. But we'll see, we'll see.

Daniel Brennan

analyst
#57

Interesting. We're almost out of time. Maybe -- it sounds like in the first half of next year, maybe first quarter of next year, we're going to get a little update on the personalized T-cell receptor strategy. I think you talked about maybe opening a lab. Like what are we going to learn early next year on the personalized strategy?

Chad Robins

executive
#58

So just let's talk a little bit about what it is. Every -- from a personalized product, every patient's cancer is truly unique to them. It's an n of 1. And so the ultimate goal is to develop a personalized cell therapy that specifically treats each patient's tumor. So the idea is to look at the mutations in that particular patient, at the same time, fish out that pool of receptors in that patient's blood and run essentially a closed-loop experiment on that patient and find the T-cell receptors that can essentially react to that patient's tumor and then hand over those sequences to Genentech. They could grow them up and deliver them back to the patient main domain in 30 days. And so that's the goal of the partnership. And in order to effectuate that strategy, they've made significant investments in terms of delivery, and we made significant investments in terms of building out a prototype lab where we're going to be testing our end of the strategy to see if we can get that screening process shortened to kind of the 8 to 10 days necessary so that if we're going to hit that 30 days, our part has to be able to deliver in a relatively short time frame. So that's really the goal in this personalized product opportunity, this is just a huge opportunity. But we're in the early stages right now, but we'll certainly know more about whether the prototype's working kind of later on next year.

Daniel Brennan

analyst
#59

Excellent. Well, Chad, I think we're -- that's it, 15 minutes before the top of the hour. So thanks. Obviously, sorry, we can't have a beer together, but I look forward to doing that at some point here. But congratulations on the quarter, and thanks again for being with us here and helping out with the conference as always.

Chad Robins

executive
#60

Yes. Dan, thanks for having me. Look forward to grabbing that beer.

Daniel Brennan

analyst
#61

You got it. All right. Thank you, everyone.

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