Adaptive Biotechnologies Corporation (ADPT) Earnings Call Transcript & Summary

Good afternoon. I'm Tycho Peterson. It's my pleasure to introduce our next company today, Adaptive Biotechnologies. Just a quick reminder, if people have questions or submit question function on the website. And with that, I'll turn it over to Chad.

Thank you, Tycho, and thanks for the opportunity to present at JPMorgan and also Happy New Year to you. So welcome, everyone, to the Adaptive Biotechnologies' presentation. We are the leading company in harnessing the power of the Adaptive immune system, and we're going to do so in a number of important ways, which I'm excited to share with you today. Throughout the pandemic, the world got a crash course in the adaptive immune system and the role that T cells play in fighting disease. We saw countless publications and articles highlighting the relevance of antibodies and of T cells in immunity. At Adaptive, that's exactly what we're focused on and what we've always been focused on. We read and translate the Adaptive immune system at scale to develop diagnostics and therapeutics. Adaptive had a successful year in 2021. This morning, we preannounced our top line revenues for full year 2021 to be in the range of $153 million to $154 million. representing a strong growth of approximately 56% at the midpoint range versus 2020. We also shared with you our CFO transition plan, I'd like to thank Chad Cohen for 7 years of outstanding service and for helping us through the transition period as we onboard a new Chief Financial Officer. As we look ahead into this year on Slide 4, we have multiple catalysts in both diagnostics and in drug discovery that could massively inflect the trajectory of the company. We got a Genentech development decision coming up. We've got data readouts in both the T-Detect franchise and from a new T cell-based vaccine. In our MRD business, we've got new indications, bloody testing and expanded reimbursement. We look forward to knocking these down throughout the year. Taking a look at what Adaptive does on Slide 5, our strategy is to translate the genetics of T and B cell receptors into data to develop clinical products to detect and treat disease. To do this, we use our unique and proprietary immune medicine platform coupled with our computational biology expertise and world-class machine learning from our partners at Microsoft to develop products that impact patient care to effectively allocate capital and drive growth. Going forward, we will focus Adaptive around 2 key business areas: immune medicine and minimal residual disease, or MRD. As shown on Slide 6, the immune medicine business includes our T-Detect franchise that aims to diagnose many diseases from a single sample and our drug discovery efforts, including cell therapy and vaccines. The products in this business area are largely driven by our T cell mapping efforts with Microsoft. The MRD business is comprised of our clonoSEQ diagnostic tests offered to clinicians and the clonoSEQ assay offered to pharma partners for enabling drug development. Let's get started with immune medicine on Slide 8. T cell receptors or TCRs contain the specific information about what disease signals or antigens they bind to. We have built the necessary capabilities to identify and map T cells to disease-specific antigens that can be used to develop diagnostic and therapeutic products. This data that serves as a source code for our T-Detect franchise also informs our drug discovery efforts. So I want to give you an example of how we apply this synergistic value approach of leveraging 1 data source to COVID. By mapping the immune receptor data specific to SARS-CoV-2, we were able to launch T-Detect as a clinical diagnostic, stand up a research tool for vaccine developers and for academic institutions to measure the T cell response to a vaccine, and we partnered on the design and development of a T cell-based vaccine. So this concept of one data set with multiple opportunities is the approach that we are planning to replicate disease after disease after disease. So let's dive in to T-Detect on Slide 10. T-Detect is a T cell-based diagnostic that simulates how our bodies naturally detect disease. The ultimate vision for T-Detect is to accurately diagnose many diseases from a single blood sample. To do this, together with Microsoft, we are mapping T cell receptors to clinically relevant antigens at a massive scale. We've made significant progress in our ability to identify signals in multiple diseases over the past 2 years. Slide 11 shows the current status of T-Detect's most advanced indications. First, T-Detect COVID is the only T cell test authorized by the FDA. In the autoimmune space, we now have signals in 5 -- promising signals in 5 diseases, Crohn's, colitis, celiac, multiple sclerosis and rheumatoid arthritis. In Lyme disease, we completed the ImmuneSENSE Lyme study. This is the second technical proof that our T cell-based testing has significant advantages over serology in the diagnosis of infectious diseases. We are preparing to make this test available during the Lyme season by leveraging the T-Detect COVID commercial channel to consumers. Taking a more in-depth look at T-Detect COVID on Slide 12, let me walk you through these eye-opening data showing the relevance of incorporating T cells as we assess vaccine efficacy in the wake of variance. Just last month, we published data showing that the real-world efficacy of vaccines is actually quite high despite the precipitous drop in the antibody response against variants. We and other leading immunologists in the field have shown that T cell levels induced by the vaccine correlate closely with vaccine efficacy, demonstrating that T cells play a critical role in immunity. As the virus as it continues to mutate, it's the breadth of T cell response that's taking charge, and it's actually protecting us, especially the vaccine -- vaccinated population against severe disease and death. We have the technology to measure the T cell response at scale, and we and other thought leaders firmly believe that the T cell response must be included in vaccine trials moving forward. this public health crisis is not going to end with Omicron or the next variant. Understanding the full immune response to these next-generation interventions will likely be key to informing public health guidance and ultimately in savings lives. As such, we expect that the utility of T-Detect COVID to continue to increase, as shown on Slide 13. Currently, T-Detect COVID is offered as a self-pay test to consumers to confirm past infection to SARS-CoV-2. In 2021, over 30,000 consumers ordered the test, and we have observed repeated upticks every time we experience a new variant. To further benefit patients, we are enhancing the test to quantitatively measure the level and the durability of T cell response to natural infections and to vaccines. We're currently in discussions with the FDA regarding this enhancement. In addition, we're working with both academia and with our biopharma partners to expand the use of the test as a correlate of protection. Moving to Slide 14. Our data is demonstrating that T-Detect could decrease the diagnostic odyssey for patients with hard-to-diagnose autoimmune disorders. We are focusing our R&D efforts on autoimmune disorders where we believe there is a large market in clinical diagnostics and pharma to enable drug development. 2021 was a successful year of signal generation. After completing the analysis of thousands of IVD samples, we now have signals in ileal and colonic Crohn's and have identified an early signal in colitis. In addition, we confirmed our signal in multiple sclerosis and have identified an early signal in rheumatoid arthritis. Importantly, these signals are at a very high level of specificity. And in 2022, we will be further confirming and clinically validating these signals and others as we prepare for commercialization of our first autoimmune offering in 2023. Let's now move on to an overview of our drug discovery efforts and our continued strong progress on Slide 16. Since 2019, Adaptive's R&D investments have successfully extended our platform into 3 drug modalities, T cell-based therapeutics, T cell-based vaccines and antibody discovery. Our goal this year is to continue to accelerate data generation and validation proof points in each of these 3 modalities. In addition, we're scaling our drug discovery capabilities to find novel targets for therapeutic use with a primary focus in the autoimmune field. As you can see on Slide 17, our drug discovery growth plan is expected to drive meaningful value creation to Adaptive with many shots on goal. Our growing pipeline includes a mix of candidates and early clinical development near IND-ready and early discovery programs. In collaboration with Genentech, we are making great progress in both the shared and the private programs. For the shared program, we have delivered our safety and efficacy data package for the lead TCR and expect an imminent decision from Genentech to advance this candidate into development. We are also on track to deliver 2 additional TCR data packages for clinical development consideration just this year. For the private program, we successfully completed the initial proof-of-concept on 60 cancer patients, and we aim to lock down and test the personalized workflow in conjunction with Genentech for the fully personalized cancer T cell therapy to prepare for a potential IND submission in the following year. Turning to our T cell-based COVID-19 vaccination collaboration with Nykode. Last month, the first person we -- the first person was dosed, and we expect data from this vaccine collaboration in the Phase I/II clinical trial in the first half of just this year. The reason this is so important is that Nykode vaccine is being administered to previously vaccinated individuals. So it has the potential to be a universal booster to currently available vaccine. As you can see, we're progressing on many fronts across our drug discovery platform, and there's key milestones throughout 2022. Now I'm going to turn your attention over to our MRD business. Slide 19 shows a strong position we have in MRD with clonoSEQ. ClonoSEQ is the gold standard in MRD testing for lymphoid malignancies with an industry-leading sensitivity. It is the only MRD test that has gone through the rigor of FDA validation. It has broad reimbursement coverage with over 240 million lives. It's used in all 31 NCCN cancer centers and all major pharmaceutical companies developing lymphoid cancer drugs use clonoSEQ as the test of choice in their trials. There's a strong synergy between clinical adoption of clonoSEQ and inclusion of clonoSEQ in pharma drug development trials, growing clinical adoption strengthens pharma belief in MRD at the same time in parallel, pharma trials raise awareness of clonoSEQ in the clinic. That is why we are going to provide additional clarity around this business area that includes both clinical and pharma together. While clinical utility has been a barrier to adoption in the past, this is changing quickly, and we see multiple studies reading out that demonstrate the value of MRD testing for patients. A great example of this is the master trial, which is shown on Slide 20, which we recently presented at ASH just last month. As you can see in the chart, the data demonstrate that if you are MRD-negative with clonoSEQ, you can stop therapy, giving relief to patients from side effects and at the same time, saving substantial cost to the health care system. Turning to Slide 21. I want to walk you through the key growth drivers for the MRD business and why we are poised to lead this field. First, it is critical to continue to expand the clinical use of MRD. At Adaptive, we are investing heavily in our data generation efforts. Second, we are moving into the blood. Blood-based testing has the potential to both increase penetration of clonoSEQ among clinicians and at the same time, increase the number of tests run per patient. We also plan to expand into non-Hodgkin's lymphoma or NHL, assessing MRD from blood and from circulating tumor DNA in plasma to complement or supplant imaging for disease burden, monitoring and early detection of relapse. Specific to commercial execution, we have 2 main areas of focus: One is continuing to grow HCP and patient awareness, particularly in the community setting; and second is enhancing the clonoSEQ test ordering experience. We're increasing our field force, including diagnostic hematology specialists and account managers that we expect to be trained and in the field by the second quarter. As you can see from the chart, we are still at the beginning of the adoption curve. Focusing on these key growth drivers will enable us to increase penetration, where there are about 400,000 patients in active treatment per year in the U.S. alone. We are well positioned to increase adoption significantly and look forward to a very successful year for our MRD business. 2022 is expected to be a year filled with catalysts and multiple shots on goal across the business. Adaptive is a true platform company with many opportunities to create value. Just take a look again at our upcoming catalyst slide, which shows the breadth of these events. I look forward to updating you throughout the year as we knock them down. With that, Tycho, I'm going to turn it back over to you to lead us through the Q&A session with our team, Harlan Robins, Nitin Sood and Chad Cohen. Thank you, everybody.

Great. Thanks, Chad. Great overview. Why don't we start with the rationale for changing the business areas. You began in life science research, diagnostics and drug discovery. Now you're shifting over to immune medicine and MRD. Can you talk about thought process? And are you planning to change the way you're reporting revenues?

Yes, sure. So through these changes, we -- what we're really intending to do, at least initially, is provide further clarity into our business and emphasize our focus on the development and commercialization of clinical products. So in order to better truly understand our MRD business, it's important that we look at the combination of clonoSEQ as clinical volumes and the pharma business, which is really on par with our peers. And it also shows that synergistic value, which I described throughout the presentation. And at the same time, in our new medicine business, we want to highlight kind of all of the opportunities that stem from our platform, both on the diagnostics side with T-Detect and in drug discovery. So that's really going to help us both effectively allocate capital, drive growth and provide this clarity to the investment community. Your question with respect to kind of break out, the first step is we're working to align our revenues with these businesses. In the past, we've done this as sequencing versus development. And you will see over the -- throughout the course of this year, we're going to have kind of more of a top line breakout. And this will address a lot of the feedback we've had from kind of the investment community to improve the understanding so you can really track our business and put it on par with who we comp against.

And can you expand on the T cell data you published around COVID? Why do you believe that T cells need to be more systematically included in the past before to fight the pandemic? And do you think T cells could have impacted the decision on the failed study for kids under 5 years old?

Sure. Harlan, do you want to take that one, please?

Sure. So this is an RNA virus, and it's mutating faster than influenza. And it's rapidly evading the protection that you get from antibodies. It's likely that all of us will end up getting infected if we haven't already, I know that Omicron is ripping through the world and will likely get infected multiple times going forward because antibodies are going to be off target even from the ones generated from the vaccine towards keeping us from getting infected in the first place. But fortunately, we have T cells to keep us from getting severely ill. So that's their job. They clear infection. Once you get infected, antibodies don't really help very much in getting rid of the infection, you need T cells to do that. So in this new state, where we're hoping we're going to move from a pandemic to an endemic situation, it's going to be T cells that are going to allow this. It's creating enough protection that will prevent serious illness moving forward. And Adaptive's really worked hard to create a practical solution. Obviously, this is -- none of this holds water, you can't actually make this measurement anyways. But we've worked hard to change the way people normally measure T cells or have traditionally into a molecular assay that can be run robustly at scale and comparable across samples collected all over the world. So we think that there's -- we're kind of ushering in a new era in how we evaluate efficacy of vaccines. But yes, you asked also about the trial for kids -- kids under 5. To be honest, this was the first time -- this was probably the most upset I have gotten related to our decision-making as a country. I'm obviously a little bit biased because I have a 4-year old. But the -- I don't know if everybody knows this, but the only -- they didn't -- the trial, they didn't measure efficacy of the vaccine. They didn't measure -- they didn't even measure or look at the T cell response. They only measured the antibody response to this virus and said that it wasn't -- with the small dose they gave these kids, it wasn't sufficient for them to reach their barrier bar and say, okay, we're going to allow this vaccine to move forward. Now would it have been different if they had measured T cells, I mean, which is what we really want anyways. We want to prevent kids from getting really sick. They get infected and have mild symptoms. Okay, that's not the worst thing in the world. So yes, that was a bit infuriating to me. And hopefully, we can -- we would -- hopefully we can amend that going forward and develop the data moving forward so that we could have potentially approved a drug based on what we hope it will really do and just keep kids out of the ICU and keep kids from getting sick.

And then maybe a couple of follow-ups on T-Detect COVID. You sold over 30,000 tests since launch. How does that compare to your own internal expectations? And how do you think about the uptake in trajectory in the near-term and then durability as the pandemic subsides?

Sure, Nitin, will you take that one, please?

Yes, you are on mute, Nitin.

Yes. So thanks, for directing that to me, Chad. In 2021, we sold 30,000 T-Detect tests, which certainly exceeded our expectations. The interest in the assay accelerated in the second half of the year, driven by the delta variant. And obviously, patients interested in understanding the immune response to the virus especially T cell activity associated with vaccination. And we saw the same trend with Omicron. And our expectation is that T-Detect COVID will remain relevant for both clinicians and patients as COVID becomes endemic and particularly for immunocompromised patients, which is a sizable population of 7 million Americans. We're looking to really understand their risk, their medication choices, understand their level of immune response to the virus. And I think given that we're -- we think that the test will stay relevant, we're continuing to invest in the test. We're in discussions with the FDA to add a quantitative measure of level and durability of T cell response to national vaccines -- to national infection and vaccines. We're working on generating data to demonstrate correlative protection, which is looking at individuals who are vaccinated, got breakthrough infections and looking at individuals who are vaccinated and didn't get breakthrough infections. What the difference in their T cell responses and what that tells us about the level of protection. And all in all, I think all these enhancements we make to the product will continue to keep T-Detect COVID very relevant even as the disease becomes endemic.

A couple of follow-ups that came in on e-mail. Can you just touch on the competitive landscape for T-Detect COVID, including upcoming competitors?

Yes. I think on the T cell side, we are -- the test that's been FDA-approved for measuring the depth and the breadth of T cell response particularly using immune repertoire sequencing. We don't see anything out there that directly competes with us. There are other T cell measures, but they don't measure the way we do, which is, we are able to look at all the T-cell sequences and individual T cell sequences, the sort of the depth of those sequences or how amplified they are. So I think we're feeling pretty strong about our position in response to the product.

And then can you comment on the tolerability of the T cell vaccine, if tolerability can scale between flu shot and a more cumbersome mRNA shot, where would this lie as a booster in your view?

Harlan, do you want to take that?

Sure. So far, the data that we've seen that Nykode's developed has shown a great safety profile. I mean, obviously, they haven't reached the full -- when you start reaching tens to hundreds of millions of people, you can find very rare things. But so far, it's been extremely well tolerated, and I don't think we have -- that's not our primary concern. So I think the safety profile looks really good.

Maybe just stepping back for a minute, the concept of one data set for multiple opportunities. You know you gave some good examples around COVID. Can you help us understand how you envision this playing out in other disease states?

Yes. Sure, Tycho. I'll take that one. So maybe let's give another example in the autoimmune space and take rheumatoid arthritis. So if we're able to map RA-specific T cell receptors to RA-specific antigens, we can then do a lot of different things with that data. So the key is to understand that for autoimmune disorders that these disease-specific TCRs, they're actually part of or even positive of the disease pathology. So those kind of -- once we identify them and what they are on the diagnostics side, the idea is that they can be used to diagnose patients earlier in that kind of diagnostic journey or they can be used to segment patients for therapy selection or even monitoring down the road. And these diagnostic clinical use cases, those would fall kind of under the T-Detect franchise. But at the same time, the idea is that these disease-specific TCRs, they can be used to potentially create new therapies and/or the specific antigens can be the new therapeutic targets themselves that we can block. So we're already started and we're in kind of in active discussions with several pharma partners for different opportunities, both in cell therapy for AI and other target discovery opportunities that could really stem from this mapping efforts. And all of these then would fall under our drug discovery efforts. So that's just another example and where we see kind of that same example we took with COVID and applying it to one autoimmune disorder.

Maybe we can hit on a couple on clonoSEQ. You've got a couple of things going on here in the near-term with obviously Omicron, but then you've got the recently launched IGHV improvement, which should be a nice tailwind. How do you think about the trade-off between those 2 in the near-term?

Sure. Nitin, I'll have you take that as well.

Yes. So I think in Q4, we saw our quarter-over-quarter growth was very similar to Q3. We did see a small slowdown towards the end as a result of Omicron. But overall, I would say, in 2021, we had strong consistent growth. And we're doing a lot of things going forward in 2022. We are -- we have IGHV. We are -- also we're pleased to see Palmetto MolDX LCD being finalized. So we're entering non-Hodgkin's into the cell-free DNA test and getting medicare reimbursement for that. We have -- we're participating in all major clinical trials with pharma companies. We have a handful of studies that are going to read out and improve the clinical utility of the test. And finally, we're expanding our sales team. So we started that late in 2021. And even in 2021, we are sort of midway through that process, we saw a doubling of our business in the community setting. As you know, we're very strong with the KOLs in the academic centers. And good news on that front all 31 of the NCCN institutions now use clonoSEQ last time a few months ago, it was 30 or 31. Now all 31 are using us. So that's very positive. And we'll continue to build out the sales team. We're training them. We expect to have all of that done in mid-2022. And my expectation is that the growth trajectory in 2022 will be stronger equal into 2021, I think we'll have a much deeper penetration into the accounts that we're already in, namely the academic centers. and we'll expand our penetration into the community setting. And our product is becoming more relevant given the fact that now it covers, we're going to go into DLBCL, which is the largest sub-type of non-Hodgkin's lymphoma and in the community setting, the same doc treats multiple diseases. So having a broader portfolio also increases the relevance of our test. So I think looking forward to very strong 2022.

And then the latest timing on the other blood first indications with FDA for multiple myeloma and non-Hodgkin's lymphoma. And then I did have a question on just sizing the non-Hodgkin's lymphoma opportunity as well.

Yes. Yes. So I think we are progressing with a partner on the pharma partner on non-Hodgkin's lymphoma. This is going to serve as our CD study for FDA. It's event-based. So we're not quite prepared to give any updates on time lines. But I think, as you know, in terms of penetrating into the clinical market, our test is a clear offering. We have a lot of evidence that's been generated. Even the Medicare LCD document talked a lot about the relevance of MRD in non-Hodgkin's lymphoma. They mentioned a lot of evidence that was generated using clonoSEQ. So I think we're charging full speed ahead in terms of commercialization of non-Hodgkin's lymphoma. And the sub-type that we're focusing a lot on is DLBCL, which is the largest sub-type of non-Hodgkin's lymphoma. We think there's a sizable number of patients in that bucket. The prevalence is around sort of 80,000 patients for just DLBCL, but broadly non-Hodgkin's lymphoma as a couple of hundred thousand patients.

Maybe last one on clonoSEQ. As we think about additional hurdles, is label expansion into blood basically sufficient to drive full penetration into the community setting? Or do you need updated guidelines really catalyze broader adoption?

Yes. I think -- I think expanding to blood is important to drive it into the community setting. But I think there's other catalysts as well or other activities that we're doing. And like I mentioned, we have -- we're expanding our sales footprint. We have data being read out in the mid part of the year on multiple myeloma that will demonstrate the value of the test in blood. And so all those things combined, the expansion of DLBCL will make it more relevant into the community setting. So all those things combined will really overcome some of the barriers around adoption. And again, I think 2022 is going to be a strong year.

Maybe back to T-Detect for a minute. Online, I know you're committing to kind of a back-half of the year launch. Any updated thoughts on pricing, how quickly you can penetrate that market of 600,000 or so acute Lyme case per year without reimbursement?

Nitin, why don't you continue?

Yes. So I think a couple of things I want to say there. One is, we are finishing our Lyme study. It's completed. We're just wrapping up the data. So the program overall is on track. We are also simultaneously putting a lot more energy in COVID, T-Detect COVID test. As I mentioned, it's -- we're not only going full steam ahead with our reimbursement launch, but we're expanding that product portfolio. And on Lyme, we're moving forward with the program. We're looking at all the options, including pricing options. We have now 2 paths available to us. We've seen success with our T-Detect COVID test on the physician-led consumer-directed offering, and we're seeing some uptake or some positive feedback from our HCP route. So we'll consider both opportunities in Lyme. And I think later in February, we'll give you more guidance in terms of 2022.

And obviously, there's a lot going on in autoimmune. Chad, you talked about that in your presentation with Crohn's and celiac and other diseases. What are the milestones we should be paying attention to around the autoimmune pipeline for T-Detect?

Sure. Nitin, why don't you continue?

Yes. So I think on the autoimmune side, we're focused on multiple sclerosis on IBD, on rheumatoid arthritis. I think our approach there is we want a test that's very highly specific. We're very confident about that. given the fact that a lot of these diseases, as you heard, mechanistically may involve T cells. So we want a high specificity test. We're seeing some good signal and data being read out in terms of sensitivity, we want to continuously improve sensitivity going forward in 2022. And in 2023, we want to launch these tests. And again, when we're going to look at both channels, we're seeing success with our T-Detect COVID test. As you heard, we sold 30,000 tests through the physician-directed consumer channel. So we'll -- we're considering making the autoimmune panel available via that channel. And then as more evidence generates and as more clinical studies are completed will go down the reimbursement path like we are doing with T-Detect COVID. So 2023 is the launch time line and 2022 is all about generating and strengthening our data.

And then do you think of the bulk of the autoimmune offering will be around panels as opposed to individual tests? And then how do you think about linking that to the drug development side as well, vaccines for autoimmune diseases?

Yes. I mean I think our approach is -- initially it's going to be very focused on sort of assisting the diagnostic odyssey around autoimmune diseases. We're going to bundle them around similar symptoms and similar locations where these diseases are diagnosed. And then over time, we're going to move into monitoring, just the way we've done with clonoSEQ and measuring and helping physicians make therapy decisions particularly in autoimmune disease. As you know, the number of treatment options available to patients is continuously increasing in the autoimmune space. And that's where pharma would become a very active partner and a very active player. And we already are in many, many conversations and many, many active engagements, not just conversations, active engagements with pharma companies on the autoimmune side with our T cell platform. So that will continue to strengthen with time. And again, it will be the same synergistic relationship that we -- that Chad talked about in the MRD business. Sort of adoption of the clinic drives use in pharma, more adoption in pharma that makes it more relevant in the clinic. So we'll continue to see that sort of virtuous cycle as well in autoimmune space.

And maybe furthering the second part of your question, Tycho, which I brought up with rheumatoid arthritis, but the idea is that we learn more and more about kind of these disease-specific antigens. We have the modalities on our drug discovery side, we're getting smarter in the vaccine space, getting smarter in the target discovery space, et cetera, that we hope to be able to leverage and bring that kind of data forward to really discover kind of new therapies in conjunction with our partners.

And I know you mentioned a decision with Genentech is imminent. Do you want to just maybe spend a minute on how this go around is a little bit different and how you've kind of de-risked it versus what we heard at the beginning of last year?

Yes, I'll take that one as well. And then Harlan, if you want to pile on, feel free. I think there's -- there's really -- there's 2 components to the de-risking. The first is by the biology and the nature of the type of cancer antigen that we chose this type is expressed only on the tumor itself whereas the first one, which was obviously the tumor-associated antigen was in healthy tissue and in the tumor. So just from a practical standpoint, from biologically, you don't have that same risk profile. And the second, and not that we always didn't work very closely with our partners at Genentech, but we've really tightened up and became kind of part of that safety profile work that was going on. It really was a very interactive review. Look, until the decision is made, you can't say anything is 100% or it's done. I can just tell you that we are confident based on all the work we've seen and done together. And as I said, we're expecting a decision very soon from Genentech on moving this forward into development so that we can -- so that they can kind of get -- go very quickly and sprint to get an IND filed.

And then how about on the personalized cell therapy product. Once you complete the prototype for the 60 cancer patients, what additional steps need to happen before IND readiness? And how would you kind of characterize the risks and probabilities around that one?

Sure. Harlan, do you want to take that?

Sure. So we're -- have created the proof-of-principle that we're able to in real patients generate the -- discover and pass along to Genentech, the T cell receptors that can be used in the cell therapy. So now it's really about putting together all the pieces to create a pipeline that can pass what's required from the regulators and our own internal vision of it. So it's a large amount of logistics that's integrating the cell therapy manufacturing pipeline that Genentech has created with the TCR discovery pipeline that we've created. So really, the next steps are -- they don't sound too exciting, but it's logistics side of it. It's putting together the actual pipeline. And we're actually -- this is something that's a core competency at Adaptive. This is what we've done in our clinical products already. So I think we feel quite confident that we'll be able to move this way -- move forward in a timely fashion and Genentech as well, we couldn't ask for a better partner. They're really dedicated to moving the cell manufacturing forward as well. So we've made a lot of leaps forward in the last year, and we feel like we just need to put it all together.

Great. I'm going to signal from the producers that we hit time. So I think we'll leave it at that. Appreciate you guys taking the time today. Good to see you all.

Thank you, Tycho.

Thank you, Tycho.

Thank you, guys. Take care.