Q2 2020 Adaptive Biotechnologies Corp Earnings Call
[music].
Bye and welcome to the adoptive biotechnology second quarter financial results Conference call.
This cycle participants are in listen only mode. After the speakers presentation. There will be a question answer session to ask the question. During this session you'll be superstar war, calling your telephone.
Requiring pretty good systems. This star zero. Thank you all know likes you heard the Colibri to your speaker today Ms. scurried at calls the Vilia. Please go ahead.
Thank you pay no and good afternoon, everyone.
I would like to welcome you to adopt it by technology second quarter 2020, earning conference call.
Today, we issued a press release reporting adopted financial results for the second quarter up 2020, the press release available on our corporate website at Www Dot adopted biotech dot com.
Dolphin like what cost a bit call every player which will be available on our website. After its conclusion.
I would also like me Mike that during the call management will make projections on other forward looking famous within the meaning of federal security laws regarding future events on the future financial performance of the company.
It's important to note that these statements reflect management's current perspective.
That's up to date state.
Actual results may differ materially from current expectations and protection, depending on a number of factors, which are set forth in our public filings with Securities Exchange Commission, including the forms 10-Q to be filed today.
Dr Disclaim any obligation to update forward looking statements, except as expressly required by.
In addition, nongaap financial measures will be discussed during the call are definitely not that metric.
He sent from non-GAAP to GAAP metrics can be found in our earnings release issued earlier.
During the call today, I chat Robbins, our CEO and co founder.
Everything our president and shot Cohen, Chief Financial Officer.
Yeah, They time Harlem, Robyn adopted Chief scientific officer, and coupon there will be available for keeping it with that I was kind of going over to tap low cat.
Thanks, Greta good afternoon, everybody and thank you for joining us on our second quarter 2020 earnings call.
I hope that you really loved ones are staying safe and healthy as we continue to navigate through these difficult time.
I want to start off by saying I'm truly honored to be part of your doctor team and want to congratulate my colleagues on our first year anniversary from our IPO.
The past months have been challenging for everyone in our intercompany for show an unwavering dedication and flexibility.
Thank you to all our adaptive employees.
As you all know the current grown a virus pandemic is highlighting the critical importance of understanding immune response to disease broadly.
Taking adaptive technology more relevant than ever.
Adoptive we're focused on translating the genetic to be adaptive immune system into clinical products to detect and treat disease and we're committed to leveraging our immune medicine platform to support the efforts to combat Cobot 19 pandemic.
Cohentannoudji brought the role of the immune system to the forefront of society and has created the opportunity for adoptive just to be positioned as D. 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 and each of our business areas is remarkable, particularly given the impact of cobot on all of us among the main highlights.
We reported revenues of 21 billion above our pre announced revenue range associated with our follow on offering.
And our research business, we launched a new product immuno seek T map cobot to elucidate the T cell response to vaccine and development for Coburn 19.
In our classic business, we achieved an important milestone with the label expansion into CLL.
Our first FTC approval for blood based testing.
For music Dx, we initiated two clinical validation studies, the immune sense study for Lyme disease, which started enrolling in time for Lyme season, and the immune rates study to collect blood samples from covert 19 impacted individuals.
We also published two manuscripts, which had been submitted for peer review and detail the largest global effort to map. The T cell response to covert 19 for research and diagnostic purposes.
Today, we're also pleased to announce favorable results from our head to head study comparing them you know CTX Sars Coke Q2, two meeting Surajit test to detect past infection in 100 convalescent patients in a real world setting.
And in drug discovery related to our PC. Our efforts. We're we continue our activities on the first shared product to support Genentech and an I.M.D. submission with the FDA on RBC. Our efforts we have selected to enter synthesizing over 2000 candidates to identify those that's best neutralized.
Let's go to for Android to evaluate this fall.
As you can see we're firing on multiple cylinders and recently completed our first follow on equity raise to enable 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 pressure.
Others.
No I want to give me an overview our T cell based efforts to response to coated.
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 a massive diversity of easily dependent T cells to help your body respond to hundreds of millions of different pathogens.
Therefore, most researchers including vaccine developers have continued to really rely on techniques to either measured the immune response solely based on antibody levels or sometimes using T cell to techniques that are expensive the spoke and low throughput and adaptive we set out to solve this problem several years.
Yup.
When this pandemic hit together with Microsoft we created the immune code program to map. The T cell response to Saar scope to across the population. Our goal is to leverage the existing capabilities of our high throughput platform to generate an unprecedented amount of T cell data from over 4500 patients to.
I understand the adaptive immune response to cobot.
In June we launched the immune co database to make a 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 seek was over 1400 patient samples from these samples we have map over 135000, hi.
Competence T cell receptors or Tc ours to despite protein as well as 10 other specific parts of the virus, which we have shown to be most immunogenic.
We've also demonstrated the DTC ours have promising durability since greater than 90% of patients had shares. So first coat coke to specific T cells. After 90 days post confirmed diagnosis. The maximum time period currently available to assess response.
As a result, we launched immuno seek T map cobot as a tool to offer vaccine developers a way to integrate our map of Sars codes to specific T cells into their vaccine trials. This is the first molecular T cell monitoring tool for source code to that accurately and reproducibly.
Measures a T cell immune response to vaccines and tracks the persistence of that response over time.
Finally from the map Tcrs, we're curated a set of TCR is that our shared across the population, creating an enhanced T cell receptor signature or classifier to use for diagnostic purposes. We currently referred to this as immuno CTX Sars Coke to.
To begin with we believe that this may offer an alternative test to confirm pads infection based on the T. Cell response since we are all learning the patients antibody don't seem to tell the whole story.
As I mentioned earlier, we recently demonstrated higher sensitivity versus two leading technology to us in a real world study with 100 convalescent patients. We're very encouraged by these data and believe that they will contribute to our overall understanding of the immune response to covert 19. These additional data will be published shortly and Julie will provide more details and.
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 the global pandemic with that I'll handover to Julie to walk you through more detailed across each of our profit.
Areas Julie.
Thanks, Chad and thanks to all of these for joining us today.
I really hope you and your families are safe and healthy I want to Echo Chad. Thanks to our incredible employees. It has been a busy and successful quarter during an uncertain time.
Starting with our clinical diagnostic product Kalona speak as Chad mentioned, we recently got FDA clearance for our first quarter to seek label expansions in CLL in blood as well as bone marrow. This marks an inflection point within our close to seek business added as it is our first approval in blood and doubled the size of our addressable population.
Under our FDIC 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 classy patient easily obtain blood draws outside of their doctors offices, given the risks that could be 19 poses for cancer patients.
Now patients can act that minimal contact blood collection services that any of the nearly 2000 Labcorp patient service centers in the United States or they can have a blood draw outperformed in the comfort of their own homes through adapted collaboration with legal tech solution, a nationwide provider of mobile phlebotomy services.
Following our launch a CLL implied we will continue to expand into blood testing and AOL and multiple myeloma, which enables an increase in a number of tests run per patient.
Ultimately, we plan to expand the use of clinic beacons NHL.
These efforts coupled with increased payer coverage and patient engagement set the stage for Kona speaks growth trajectory.
Well in a peak sequencing volumes grew 31% to 3136 test versus prior year.
These volumes speak to the value of clients seek MRT testing and to our ability to maintain customer engagement, even though clinical care significantly restricted for cancer patients given the pandemic.
In fact, while some of our traditionally higher order volume accounts remain closed we're seeing more meaningful order volumes from new account faster than we've seen before giving us great confidence in the buildout of our commercial infrastructure for close to seek and our pipeline.
April was our toughest month due to coded 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 could 19 closely as clinical volumes may still be impacted due to resurgence in cobot cases around the country.
Moving onto our research business within you know.
The research business was impacted the most severely in the quarter back over 19 as around nearly half of U.S. lad still being 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 immuno seek Tina Kogan, an extension of our robust entry in molecular immuno sequencing product and you know speak which quantitate T cell receptors.
The key New addition is that we are providing data that map those were sector receptors to stars cool Q antigen 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 them you don't seek to offer research customers a quantitative reproducible list of T cell receptors maps to specific disease antigens importantly, like we do with them you know seek we're 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 immuno assay, Tina covance, including those already in late stage vaccine trial. We also believe that the information we have shared about the immunogenicity of various parts of the Sars club to virus, including but not limited to the spike protein may inform next generation.
Vaccine design and development.
Now moving onto our clinical pipeline with immuno CTX and drug discovery.
For immuno CTX line, we opened our immune sense study to demonstrate the sensitivity and specificity of our test and development in patients with signs and symptoms of suspected Lyme disease.
This study will compare our T cell based diagnostic approach to current standard of care, Surajit, which has a high false negative rate, 60% to 70% in the acute line setting.
We intend to enroll 990 subjects into the study of which approximately 400 will have been clinically diagnosed with line to be the remaining subjects will be recruited as negative controls from both in deneke and non endemic regions.
There are approximately 3.4 million line 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 nondescript engines that are suspected to be caused by line.
This population is over 600000 patients in the U.S. each year.
Data from this study for the newly diagnosed cohort will be collected first and will be the basis of our submission to the FDA plan for the end of this year.
We will also be collecting up to four longitudinal samples for a year 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 line advocating organization to further drive.
Like awareness.
For me to seek the XR Coke to you heard from Chad that we have demonstrated that our T cell based diagnostic tests performed favorably against two leading surajit test 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 immune Ray study.
Research results show that up 99.8% specificity for all three tests are T cell test was 92% sensitive versus 90% and 87% for the other two surajit Pal respectively.
It is important to note that since our test is a self learning diagnostic that Leverages machine learning the classifier will incrementally and self improve every time, we sequence more samples, making the truth sensitivity of our test even higher.
Based on these data we're confident that our clinical validation study being designed currently with the FDA will give us a comparable label to serve algae test and we feel we will have higher performing tests 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 program.
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 vaccines, which may need to be monitor for possible boosters overtime.
I would like to highlight that the progress just described with Lyman Sars close to four immuno CTX not only solidifies our position within infectious disease, but also provide proof of our immuno CTX platform for the early stage diagnosis of many diseases importantly, the accelerated activity is around Sars close.
I will allow us to bring our first and you know CTX product to market a year earlier than planned.
Moving onto 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 from neutralizing antibodies against Sars Cove too.
On the first shared products with Genentech, we have delivered the data package for our lead TCR candidates against the shared the selected shared antigen.
I am decent mission 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 share crops.
We're also making improvements to our real time screening of TCR from patient blood that establishes the end to end workflow for our private product to support this programs, we anticipate opening our south San Francisco dedicated prototype lab in Q1 of 2021.
Regarding our efforts to identify neutralizing antibodies against Sars Coke too we have selected more than 2000 candidate candidate antibodies from acute where we covered could 19 patients of these the first 500 candidate antibodies are being characterized confirmed which antibodies will buy most strongly to the virus.
We expect will have identified potent neutralizing antibody candidates to treat cobot 19 by the fall at which point Amgen has an option to develop manufacture and commercialize selected candidate.
I'll now pass it over to chat see 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 and 29 team.
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 4185 sequences from 9084 sequences in the same second quarter 2019.
On the other hand clinical sequencing volume increased 31% in the second quarter 2020 to 3136 clinical tests from 2388 clinical tests from the second quarter 29 team.
Clinical sequencing volume did recover sequentially from April through June returning back to we're exiting Q1 volumes.
Although the initial impact of the cobot 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, but the 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 with $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 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, 2020, or $26 million compared to $16.5 million into say second quarter 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 immuno CTX applications in line and coded as well as quota seek label expansions in a blood.
Sales and marketing expenses for the second quarter of 2020 were $14.3 million compared to $8.9 million in the second quarter 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 close to seek 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 2020 were $12.2 million as compared to $6.7 billion in the second quarter 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, 2020 was $33.5 million compared to second quarter 2019 that loss of $15.7 million.
Adjusted EBITDA for the second quarter, 2020 was a loss of $28.5 million compared to a loss of $10.9 million in the same period over the prior year.
[noise] due to the ongoing on certain nature of cobot 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 the emanates from our immune medicine platform and will allow us to incubate our current and future opportunities.
Before I turn it over to chat 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 chat 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 are 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 hurdles to include the T cell response to disease at scale. We believe this will fundamental fundamentally change immunology.
Our futures bright and I can be more enthusiastic about where we can accomplish.
With that I'd like to turn the call back to the operator and open it up for questions.
Right. So as a reminder.
So question you will need to press star one on your telephone to lose all your questions press. The pound can again that is star one on your telephone.
For the first question, we do very weak there brings from bank of America fewer no lies.
Hi, good afternoon.
At very very Oreo.
Good good so 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 through the opportunity there for drug development and then also.
The commercial Surayud your test to me.
The if you look at some other commercial Sergey tests out there I mean, they're fairly extensive and reimbursement for standard test is around $42 I believe.
And then obviously your test is not going to be in those ranges given today's involved with it. So can you talk a little bit about the reimbursement opportunities how you're looking at this and just said we can get a better centered and the question just like any initial conversations about how payers are looking to two.
Have you any conversation payers at this point thanks.
Do you want to take a municipality Mepco Rick.
Sure absolutely had there.
So the way, we're thinking about pricing for and unit seek T map coded. It seems it's really an extension of our existing fee for service offering for immuno seek 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.
C and the other is what we call the technology access fee for that data analysis, we're actually keeping the per sample sequencing prices seen because it's the same.
Your blood sample that we typically run and we're increasing the technology access fees to enable annotations from the antigen, Matt. So we see this as hopefully a nice seamless way to continue the work that we already do with most of these companies and you know really treating it as an extension of.
Our of our existing sort of bread and butter and seek offering.
And with respect to your immuno CTX co bid. We're currently in discussions with repairs were discussing pricing across the board right. Now we recognized sequencing touched by nature is going to be a more expensive test then.
Antibodies relative you test. However, we also do believe.
As as was mentioned during during the.
During the.
The script that we 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 kind of what how much better. It is we're also assessing the pricing, but we're not there yet.
And in Julie the any idea and just sort of besides the opportunity.
Short Axio developers, just I have no idea emphasized that market.
Sure. So the way that were breaking it down and we're looking into three main variables. One is all of the program by fees 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 fees. We look at the number of patients that are needed for each of those trials in each of those phases and then we have an estimate for the number of tests per patient that we think would be.
Ron on these trials in that varies of course by the phase of the study and that's kind of.
Of course yield you will assign a penetration estimate on two to that calculation of volume.
So I you alluded to this in your prepared remarks, which you expand a little bit on it I given what you've learned from year to me. Okay initiative, how do you feel about the development of a vaccine targeting despite first grade is targeting despite protein going to listen to nothing immune response or do vaccines it'd be targeting other areas of iris as well.
Hi, as Harlan.
So we hope so but certainly in a natural infection. It's it's in terms of the cellular immune response, it's a relatively small part of the overall immune response. The there is obviously the possibility that if you only put the spike protein in as as your antigen and as in a vaccine you you could have.
With a a much greater response, because you're the immune system doesn't have the opportunity to hit the entire virus just that one gene.
But neither.
Probably.
I should just say, we hope for the vast but but we'll we're will measure it and be able to directly evaluate the difference.
Got it and I guess on.
Yes.
Just said an unrelated question.
So can you talk a little bit about your wind disease pricing strategy.
Sure absolutely you haven't.
Yeah sure so HM.
Pricing opportunity for lime or the way, we're thinking about it as we talked about in the path. 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 onto the chronic population over time, we've done a first round of pricing research today.
And the price range, we're still focused on in is in a sort of six to 800 dollar price range per test and that's due to a lot of feedback we get in their research that line patients are actually quite expensive to the system. We are continually 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 truly how much of a.
How how much better does your test need to perform.
In order to get sort of that sort of premium pricing relative to the other surajit tests around market to be real acknowledging that they are pretty crappy, but how you know what's towards the differential much you think you need to show in the trials to command a premium for that nature.
So did 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.
Are really a big difference in what we're also hearing from just the patient advocacy work, we're doing and what happens to patients who were on these sort of diagnostic Odyssey is that I've been here from our familiar with.
That's I think what why we believe we will be able to command a.
Higher price there are also LD tease out there that patients go to all the time that are even more expensive than that.
Because I just think theres a lot of frustration with the current testing paradigm and the resulting.
Frustration that the.
Now I'll use the same we're here now in the news these sort of long haulers field and the payers are quite aware of it.
Great. Thank you very much.
Thanks, Eric.
Next one on the line is tight Tyco Peterson from JP Morgan fewer normalize.
Hey, thanks.
Maybe just a follow up clearly on the on the T map offering I know you talked about the pricing structure and 100 took your so trials, but can you just give us a sense of the number of projects that are that as you can cleanup offering now and how material it could be in the back half of the year, we're trying to kind of get a framework here.
Sure. So so we launched the product last week. It if it's very new the great news is that the feedback has been very positive and working advanced discussions with with vaccine manufacturers in all phases of development.
I think it's it's probably a little early to tell exactly you know what to expect over the coming weeks and months, but we're.
Getting very positive feedback and we believe that Unifi T map and is really critical as we all hope for a persistent application 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 Ti.
Cells and I think that is definitely resonating.
Okay, and then on the on the clinical Cobot test.
Besides clinically utility and share versus or allergy can you just talk about how you're going to keep bringing that to market would you potentially partner with somebody do you need to build out on a channel what looked at what kind of resources to put behind it.
Sure. That's a great question. So initially on the T. cell based alternative to Suralco Gi and 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.
We believe that we can handle the capacity for that first tranche of testing commercially with the infrastructure that we had in our lab that would be run much like the way caught us because today.
Having said that as we continue to generate data is really a 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 come for preexisting immune.
D., we are planning for extra capacity with a commercial lab, one or more than one commercial labs to make sure that there would be on the ability to to run. This test more frequently and we also are looking into.
The ability to include our existing are you all kit in the way discussions that we're having with the FDA. So we have a variety of pass that we're exploring but we would be starting with let's send out test much like the way we run on you know seek to that closely today.
And then on on coma seek I'm on the FDA approval for for CLL start for blood first I think you could talk last quarter about maybe more more volume would shift of what first anyway in the cold environment. So has your thinking kind of evolved here that you would put additional resources by mobile Bob you mentioned, the Labcorp and the home testing offerings.
I'm just curious if you are considering kind of accelerating some of that given the current pendant.
So I guess, we feel we we definitely put in place the ability to accelerate that by working out partnerships with Labcorps ends lipo Tech. So now there's a variety of convenient and flexible safer options for patients to obtain blood draws.
For Conus Beacon would these partnerships were announced towards the end of July but we're already processing off first couple of orders from from clinicians and patients with utilize these offerings.
So you know I think we're also we're also looking at a 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 you know the 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 its alternatives, but in the future. We do believe it will be a real driver for the classic business.
And just yet.
Hi, Good we know also with the FDA clearance of 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 you'll you'll see will give you marketing towards direct to the consumer to patients as well, which should potentially drive our drive volumes.
And last one on immune raised when when do you think your list we could see data from the trials. Thanks.
Yeah I take it.
So.
The a variety of the of the data we've we've we've been making public as we go under our immune code study with.
With Microsoft So a lot of the data is available our our clinical data and the we're planning to.
Send run a critical validation study using using some of those samples and and the fourth quarter. This year. So that's when would be made available.
And separately from that.
We just had a publication on some of the immune co data.
Last week, and we'll probably have another publication coming up as well.
Great. Thank you.
In fact.
Next question comes from Dog, Sheffield from Cowen fewer no lies.
Hey, good afternoon, guys and thanks for taking my questions.
I'm just wondering if there's any updated on how youre are going on with private payers are turned for getting paid on bought this testing for AOL and multiple myeloma.
That occur there obviously, there's a nice addition for your in terms of getting them onboard are relatively recently I'm. Just wondering if that's helped you are candidates will not come on the private care side.
Yeah, Hi, Doug Yeah, we continue to make progress on the private payer side as you know.
For the more going one by one through the private payers and through the Healthtech assessment bodies.
What we do believe that.
The FDA approval on COO gives us an opportunity to engage them for coverage on the COO front as well, although not although not required it's been.
Been certainly helpful, but where I would say, we're making incremental progress on on your blood based testing from a prior private payers.
But but it's still a pretty small percentage dug in terms of our overall test volumes. It's it's a larger percentage of CLL obviously.
A smallish percentage of AOL and something Thats pretty close to zero in terms of my level.
Okay got it that's that's helpful detail.
What are the things I think you talked about in your prepared remarks marks excuse me. It was darn good momentum you had with new accounts about playing a key role this quarter for quarter suit.
No I know, it's that's in the Grand scheme of things still small volume, but still early days, but it was good relative to what we were looking for I'm just curious.
It's really.
We are really upon kind of just gaining.
Human Curt how you go about milling arm or do you think that this was some of the carryover and really just for reward of some of the stronger you put in pre count Donna.
[noise]. So I'll go back and then maybe other people want to jump in and you know I really think this is the kudos to the quantity commercial team, who who who truly really understands how to build this market and build relationships with clinicians in this market for you know that sort of.
You know.
Gross that that will start we're starting to see now exactly exactly as you said in for example on even during this year with Toby.
The team signed over 400, new HCP is and those HCP is are really starting to use the product a lot faster. So on in 2020, the new HCP has contributed to around 15% of the test volume in Q2 and at this time last year. The new HCP is in 2019 contributed about eight per.
None of the total test volume in the same quarter. So you are 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 cobot environment and there's a lot of trust that's been built between the team and the clinicians and particularly also in risk.
I want to the things that we're putting in place to make it easier for patients to continue to know their MRG status, even if it's challenging for them to go into an inpatient clinic.
So I think it's really been okay. Great effort led by the team where we continue to add new accounts, new age from keys and faster time to order for the HCP.
Just one other database probably directly or Parker.
Just because you're one of those data points that I find relevant.
We had some of our major historical.
[laughter] shut down because of the pandemic. So these numbers were put up despite some some of the cancer centers being closed that a few traditionally contributed significant significant amount of a order test volume.
You have you guys a significant amount of new accounts.
Over the year in particular in Q2 during a pretty tough time. So I think you a lot of the efforts that the team had put into place at started to pan out.
Great.
And maybe just one last one on product pipeline and weaker milestones. This group this year that upper arm.
T cell therapy product from Genentech is expected to be ready for iron be filing.
I think you said in Q1 of next year, which is great news, especially given some concerned more broadly at that time lines could slip just given what's going on in the world.
Beyond that I'm, just wondering if there's any developments in terms of other T cell therapy products from Symantec.
And 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.
Moving on 2021 beyond that first.
Thank you.
Hi, guys go out Oh, probably path to Julie for the milestone comment, but I can talk about buying but.
Yeah were.
We're moving ahead and quite rapidly into direction. So the the products that were that we've been discussing that we're gonna go to I, Andy filing and hopefully clinic in first quarter is our first shared product.
We're also working diligently on a second chaired product that we're actually building a library, but the second one we're hoping to to transition to Genentech I'm actually quite soon.
And then separately were the real goal behind all this is our personalized product we're going to create.
An individual therapy for for each person by pulling out there T cell their T cell receptors, and then putting them back in with a a transplant.
And that requires a build out of facilities in both genentech and adaptive are building out.
The required facilities with the goal of having those.
Been running for sort of early early twenties 21 or so.
First quarter as well and then throughout next year working on.
Getting that that work flow and pipeline down.
And hopefully moving at the end of next year towards towards filing.
And Julie I.
I don't know sorry, yeah.
In terms of mile sure and in terms of milestone payments, we expect a milestone payments upon R&D acceptance and upon first in human for each product you haven't disclosed the amounts of those milestones, but they are made the first in human follows shortly.
The from accepting and you know obviously.
Well Genentech and you know.
Certainly controls the timing for the R&D file pardon.
Okay. Thanks again.
Thanks, guys. Thank you Doug Thanks.
Next went on a curious saw being Richard from Goldman Sachs. Your NOL lives.
Good afternoon. Thanks for taking my question. So just to me I'm, one with regard to see head to head study with your T. cell based diagnostic tests could you tell for their here and to the data and know how confident you were in this and with the with the comparator arm.
With regard to the Surajit test and then secondly.
With regard to the TCR programs with with Genentech when will you first this when will you disclose the first target here.
Okay. So how does Harlan.
I'll start with the first question, which is on our.
T cell based test that would be competitors or this or allergy test.
We actually feel quite quite good about the data I mean, we did a real world study.
And we focused on patients where.
They were in the spot where where the surrounding tests is valid meeting. After four of these were convalescent patients at least 14 days past diagnosis.
And the majority of the subset I think.
Six or six or seven of the patients where where.
Our the adaptive test I did not show showed negative.
With with also showed negative by Suralco D.. So we we added massive overlap between the two and the and the the big Delta between them was a set of patients that adaptive we're able was able to find is positive and surajit was not so so I think we feel quite good about the data obviously, it's not a massive study yet and our credit.
Oh validation study will be that we're going to go to the for easy way will be bigger. This was a test to just make sure that weve really.
In a fair way understood the data and understood our expected results.
And the grey part is that that were also.
Our test continues to get better over time, that's where we're at right now and so thats 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 and the entire population that are specific for Sars co two and we've only uncovered.
Set of a few thousand so far and everyone. We uncover makes our test better. So so we're moving in a a very good direction.
Great. Your second question was about when we were when you would know that target and the first target will be disclosed at the time of the I envy filing by Genentech.
Which is expected again in the first quarter.
Thank you.
We have disclose it's against a solid tumor targets.
[noise] [noise] next one on the two is Brian Weinstein from William do fewer no lives.
Good afternoon.
Hey, Brian there right.
So curious if all the work uncovered 19 is helping advanced discussions with partners or potential partners and anything beyond covert 19. If you guys are we are able to showcase your capabilities, which obviously would be more important to longer term.
On that.
Oh, yes, that's a great question, Brian and the answer is absolutely we've been in discussions about mapping T cell receptors against versus antigen for multiple disease States that I think the fact that we could do.
Do this quickly when cobot came up released the data in a publicly available database ensure capabilities has catalyzed some additional discussions that we've been actually ongoing for Rio for with several partners.
I'm sorry.
Sorry, I was going to add something interesting.
You know the initial proof of concepts for our ability to map.
Receptors to antigens wasn't CMV and but now that we've actually offered T map come some of our academic groups that we work with have actually started to app now, they're like Oh, now I I really understand it.
Can you can you give me the information for CMV also you know so it's interesting that it's it's actually helped to sort of.
Terrify, what is possible from our platform disease by disease, and I think it's actually putting into context.
Some of what Weve sort of explained and in past that it's coming back up for other disease States, we've done and new disease. These new disease state that we can do.
Great and then as it relates to the work with Amgen to you guys gave a little bit update there but.
Can you just talk about your confidence.
Youre probably to kind of fine.
The you referred to ask called the M. Jay of.
Neutralizing antibodies here and then engines willingness to commercialize how you're seeing that that market sort of play out.
Yeah.
I think we're feeling pretty.
Pretty confident where we've been a going at this quite broadly and moving through a very large number of potential antibodies.
And screening from from hundreds of people now and.
The data is the data is looking quite promising you know there's a there's a some other groups that are ahead of us than seem to be doing quite well the regenerons. The world for example, but yeah, we're going after quite different targets, they're all pretty focused on on the spike protein and so.
As if we are finding if we need more abroad.
Targets. Then then the initial group is finding because which we expect that the efficacy is going to be hopefully reasonable from some of these first movers, but but but probably you know as you can imagine no one's perfect. The first time. So so we think we would have a lot to add.
As for Amgen were.
Well, we're going to present them, our best case, and they have a lot of factors to consider but but they're pretty open to and excited about.
About the concept and so hopefully hopefully that at the timings right. We're on schedule as far as our initial plans with them and so we're all things are moving well a lot of effort going on in our various lab. So we'll update you as we.
Move forward with both our own progress as well as discussions with them.
Great and then last one from me if I could sneak one in here just to confirm that the pricing in the reimbursement onboard versus bone marrow, there's really no different.
For for CLL, and then did you guys talked about the timing.
And our multiple myeloma, if you did I think I missed it if you wouldn't mind repeating it I'd appreciate it. Thank you guys.
Sure. So CAD you want to take that pricing question I'll answer. The question. Yes. The project questions is exactly the same for slot broader bone marrow and actually to.
My question earlier, some some of the protesters don't want to specify sample type either but the but the pricing is the same.
The second question.
Sorry, Brian So Ll and them in blood, it's Joe do you want to cover.
Sure.
So the.
And I'll work the data has been generated everything that's required for filing to the FDA and we are gonna be beginning those conversations now that CLL is winding down so that'll battles to startups in those discussions with the FDA.
Okay. Thank you guys.
Thanks, Rob Thanks.
[noise] next one on the Q is Davies Westenberg from Guggenheim Securities You are not alliance hi, Thanks for taking the question and thanks for all the work you're doing a easily with Kevin So.
I guess my first one is probably for Julie but it might be for Chad in terms of corner seek I mean, I would think the temptation is to order at more frequently as more information is obviously.
More and better than last information. So could you maybe talk about the behavior of the earlier adopters is the 1% or maybe if you have your customers that order the most frequency.
What is the 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 of if you could test all the time, how frequently would you test.
Oh.
Sure I'll take that I mean, with you here to really talking about the power users and depending on the indication, but in <unk>, but in LLC and most of my almost so far we have clinicians that are testing 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 overtime for for looking looking for spikes back up and to provide kind of clinical clinical decision, making based on that information.
Got it. Thank you very much and then in terms of I think Brian might have been get trends.
Been asking is similar kind of question, but in terms of yeah, Amgen and the timing for them to get a product once you given the antibody so I'm not kind of familiar with how long the the Canada It would take.
That so you have like I kind of good estimate on that.
Yeah, we're actually going to logic is the specify exactly but I can just tell you. It's a pretty short fuse by design and construction that you know if we have something it's either taken to move on and that will allow us the optionality to that's got to another partner I think.
Both both parties recognize that the external landscape is moving very quickly here. So we wanted to kind of flexibility to if the can you quantify into to go quickly and in written just.
In amgen's were since they would control that timeline, the what but amgen.
Their words are months not years, so they would be motivated to move faster obviously there is no.
This world, including very fast.
Got it now that's that's helpful. And then you know I I need a cdx you know you've talked about you could run so many different studies in parallel I think you've said 678 projects.
At a time now you have a building you have a lot more you build that you're building a building you have a lot more cash is that you know in 2021 do you maybe Ron.
More programs than that at one kind of kind of help us understand how fast these clinical timelines could go.
Sure that's a great great way of phrasing that question. That's absolutely wanted 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 yeah indications in each of the five stages now and so.
Well really really learning how to do this how long it takes what it really requires how to hone the TCR signatures and move the disease.
Diseases through that funnel. So we're we're we're really focused on this and that that as you mentioned is is one of the beat main reasons for for the rates.
Alright, thank you.
San Bruno for a good question on the Q human confused.
Ladies and gentlemen, this concludes todays conference call you may now disconnect.
[music].
[music].
[music].
[music].