Q1 2024 Personalis Inc Earnings Call

Participants

Aaron Tachibana; Chief Financial Officer, Chief Operating Officer, Senior Vice President; Personalis Inc

Christopher Hall; President, Chief Executive Officer, Director; Personalis Inc

Richard Chen; Executive Vice President - Research and Development, Chief Medical Officer; Personalis Inc

Thomas Flaten; Analyst; Lakestreet Capital Markets

Arthur He; Analyst; H.C. Wainwright & Co.

Presentation

Operator

Good day and welcome to the Personalis First Quarter 2024 earnings conference call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Mr. Aaron Tachibana. Please go ahead.

Aaron Tachibana

Thank you, operator. Welcome to Personalis First Quarter 2024 earnings call. Joining today's call are Chris Hall, Chief Executive Officer and President and I am and then touch upon our Chief Financial and Chief Operating Officer, and Rich Chan, Chief Medical Officer and EVP of R&D.
All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements within the meaning of the U.S. securities laws. For example, in statements regarding trends and expectations for our financial performance this year and longer term cash runway, revenue expectations and timing, reimbursement goals, size and booking of orders, products, services, technology, clinical milestones, the outcome and timing of reimbursement decisions, expectations for our existing and future collaboration activities, cost expectations, our market opportunity and business outlook.
These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations. We encourage you to review our most recent filings with the SEC, including the risk factors described in our most recent filings. Personalis undertakes no obligation to update these statements except as required by applicable law, our press release with our first quarter 2024 results is available on our website, www.personalis.com under the Investors section and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. The recording of today's call will be available on our website by 5 p.m. Pacific Time today. Now I would like to turn the call over to Chris for his comments and first quarter business highlights.

Christopher Hall

Thank you and good afternoon, everyone, and thank you for joining us. I'm very proud of our team at Personalis as we continue to fight cancer with our novel technologies. For those of you joining one of our calls for the first time, welcome. Personalis is one of the leaders in the fast-growing MRD testing market. MRD. stands for minimal residual disease with our first-of-its-kind ultrasensitive MRD test were able to spot cancer when it's only one fragment of tumor DNA circulating and 1 million DNA fragments of the plot. Our technologies are used by many of the world's top biopharma companies to improve clinical trial results find new ways to personalize treatment and power, a new generation of more effective therapies.
Last quarter, we laid out a strategy to drive Personalis to $100 million in revenue in 2025. This aspirational milestone with three underlining growth engine is our Lodestar as we are accelerating Personalis into a higher growth mode. In the first quarter, we achieved revenue of $19.5 million, exceeding the upper end of our guidance of $18 million to $19 million.
Our biopharma business grew 55% compared to the first quarter of 2023, driven by strong demand for our core immunoassay platform to support the individualized neoantigen therapy market as well as increasing demand for our MRD. product mix personal. With this increased demand, we have the confidence to increase our full year revenue guidance to $76 million to $78 million from $73 million to $75 million.
I'll now review progress this quarter on the three growth engines driving us towards our $100 million in 2025 goal and our progress on each in the first growth engine is the most important is we focus on turning Personalis into a clinical diagnostic powerhouse. In order to do that, we are executing on our win and MRD. strategy for the emerging market involves using liquid biopsy to find evidence of minimal residual disease or cancer recurrence and subsequently monitoring therapy effectiveness. It's estimated that this market will mature into a $20 billion opportunity over the coming years. And we are establishing Personalis is a leader in this space. Our win and MRD. strategy has four pillars, first to focus and launch our test in cancer types where an ultrasensitive liquid biopsy tests and unlock significant value for patients, payers and partners. Second, to drive reimbursement by developing robust clinical evidence of partnering with top global collaborators.
Third, leverage our deep relationships to accelerate adoption by biopharma partners and power our revenue growth by the use of NeXT Personal and clinical trials, and lastly to commercialize next partners, our NeXT Personal with a partner-centric model development. In the first pillar, we've previously explained how we're developing evidence to support next personals clinical usage and reimbursement in early-stage lung cancer, breast cancer and immunotherapy monitoring. We believe our ultra-sensitive technology allows us to see cancer earlier, which may provide the information to deescalate patients from unnecessary and necessary therapies and procedures potentially sparing patients from toxicity and saving healthcare dollars. Just as importantly, we believe we can identify and get recurrent patients to treatment earlier with potentially better outcomes.
Our focus on these indications is intentional, and our data has demonstrated that NeXT Personal can win in these markets to elaborate a bit on our approach for early-stage lung cancer and breast cancer should variable DNA into the blood, which are difficult to detect without an ultrasensitive approach. Early Detection is critical in these indications for patients on IO therapy we believe the potential decision to switch treatment requires the insights from monitoring that are provided by our ultra-sensitive test.
Now you may recall that last October we launched our MRD test NeXT Personal. And today we are enrolling physicians in an Early Access Program or EAP. We are the first ultra sensitive MRD test to commercially enter the market. And with that, and with that launch, we now have two laboratory developed tests or LDTs on the market, the other being our Medicare reimburse test NeXT Dx, which is used by physicians to put a patient on targeted therapy. The adoption of these tests has been rapid and is exceeding our initial target. We delivered 338 clinical tests in the first quarter, a solid uptick from the 126 results delivered in the fourth quarter of last year. We're pleased with this traction as the number of physicians that were ordering in Q1 remain fixed at 10 through the quarter.
There are two key metrics that I wanted to talk about a dive into. First, all 10 of our early access positions are ordering and uptake has been strong across the entire cohort.
The second metric involves the actionability of our NeXT Personal MRD test for the clinic. If you remember, we report circulating tumor DNA in the blood down to one part per million, which means if there's just one fragment of tumor DNA circulating tumor DNA fragments in the blood, we expect to see and quantify it. This is a leap forward for the field. The extra sensitivity we report on with our NeXT Personal assay, which are values between 1 and 100 parts per million mask a region that has previously been hard to see consistently, we call that region the ultrasensitive MRD. range until next personal clinicians cannot return routinely detect cancer recurrence at that level.
And today they can about 40% of the CTDNA positive samples thus far in our clinical testing have been in this ultrasensitive range. That's a significant jump in the performance of MRTD. testing and means that physicians can see cancer recurrence earlier, have more discrimination and monitoring therapy and have more confidence that CTDNA. patients that are negative are likely cancer free. Indeed, we've had many dose relay from our channel early access doctors that the ultrasensitive range is allowing them to see cancer earlier with their patients and intervene to get them the management they need. We believe it is equal ultrasensitive range that allows the doctor to see cancer sooner and seen it sooner is the cornerstone of our wind and MRD. strategy.
Now moving to the second pillar. We're focused on building and publishing clinical evidence to gain reimbursement and are working with many of the top thought leaders in the world. In previous calls, we've talked about the importance of our work with Royal Marsden in breast cancer and BHIL. immunotherapy monitoring both of these collaborators and provided access to studies that are broad and comprehensive. In the case of Royal Marsden, one of the leading global institutions in breast cancer, we're focusing on patients with early-stage disease for several subtypes, including ER positive HER2 positive and triple negative breast cancer for VHIO., the work is pan cancer across many cancer types and stages.
These studies are anchor studies and that they will be the backbone of our efforts to gain Medicare reimbursement for Royal Marsden for early-stage breast cancer and VHIO. for immunotherapy monitoring. We're excited that at the upcoming ASCO. conference to work with both of these collaborators will be featured as oral oral podium presentation. We also have three other studies featured at ASCO. one with Dana-Farber on Her two positive patients, another with Duke for immunotherapy monitoring for gastric patients.
And lastly, one in colorectal cancer patients. Having this breadth of data should underscore our commitment at Personalis to developing rich data to support the use of NeXT Personal in the clinic and to gain reimbursement quickly at the AACR conference in April, some compelling data was presented our collaborators from the UK. You gave an oral podium presentation on late-stage melanoma patients where they use NeXT Personal to monitor and detect immunotherapy response, highlighting the importance of detection of CTDNA. and the ultrasensitive range.
In addition, our work in collaboration with AstraZeneca on their matrix study was presented. The Matrix abstract show NeXT Personal achieved very strong sensitivity and specificity on blinded test samples provided by AZ down to the lowest levels at two parts per million subsequently, we were selected as a partner by AstraZeneca for MRD testing in their upcoming trials. We've also presented data from collaborators with a personalized cancer vaccine company and our analytical validation data for NeXT Personal that was recently published was also it was also at the ACR conference.
The third pillar of our NeXT Personal strategy is to leverage our biopharma relationships to drive the use of excess personnel in clinical trials. We're engaged with most of the world's top of biopharma companies and have continued to generate excitement around our NeXT Personal test. Most recently from discussions at ACR, customers want and need an ultrasensitive approach to ensure that the most appropriate patients enter into a clinical trial.
For example, we believe that our ultrasensitive assay means that patients tested negative are much, much less likely to have a recurrence. Our biopharma company customers can then expect that these patients are less likely to benefit from a therapeutic intervention holding out the promise that NeXT Personal can be an excellent approach to optimize bar at biopharma trials. Indeed, here in the first quarter, we booked a record new orders for next person product helped to drive our strong Q1 financial performance, and we believe it will be a driver of revenue moving forward, an important way for us to deepen the clinical utility of X personnel.
Now I'll move on to the fourth and final pillar commercializing X personnel using a partner-centric model. In December, we announced our key partnership with Tempus to commercialize NeXT Personal Dx.
Next personal in the clinic with oncologists to quickly review, we expect to leverage Tempus up to up to offices up to approximately 200 person sales channel to co-commercialize NeXT Personal and accelerate growth. Personalis will be responsible for processing samples in our lab, obtaining reimbursement and invoicing health insurance payers and patients under the arrangement while paying Tempus fair market value for the commercial services they provide to us.
Overall, the deal is worth approximately $30 million for Personalis, should all the milestone payments triggered. And if Tempus fully exercises their warrants. We expect this to allow us to ramp up commercial efforts quickly with minimal additional cash investments. We plan to launch with Tempus this quarter by expanding our early access program to include some of campuses clients. The goal is to learn how to work together as partners, integrating our business systems for funding our message to oncologists. So we're set to drive accelerated growth together on the backside of reimbursement approval.
Now while we made strides with our first group growth engine, our winning marquee strategy to establish ex personal as a leading EMR key tests. We also made progress with our second growth engine, leveraging our immuno Idenix platform to deepen relationships with biopharma customers who use the offering to pioneer new therapies. Our biopharma segment grew 55% year over year, and we had solid performance across our product portfolio. Customers primarily use our immuno IDX. platform in two ways. First, they use our platforms to power translational research and find new biomarkers and new insights that can power their drug discovery efforts.
Second, companies in the personalized cancer vaccine market use our platform to create a molecular fingerprint of a patient's tumor to power a personalized therapy. We previously told you about our partnership with Madonna and which maturities utilizing our platform and their mRNA cancer program matured and its partner, Merck are enrolling patients in our collaboration with modernity important driver of revenue for us in 2024 and 2025. We have several other partners that work in this space as well for their growth engine.
Third engine of our growth strategy is growing our personnel inside approach as we service enterprise customers and these relationships partners adopt our platforms and technologies to power their solutions and provide new insights to their customers. Our work with Nanterre involves leveraging our sequencing platform to analyze the exome as a part of their MRD product. We believe our relationship is strong and mutually beneficial and are optimistic that will extend into 2025.
The second important enterprise relationship is the VA the VA utilizes our whole genome sequencing capabilities to power the federal program and national research program.
Looking at how genes and lifestyle affect the health of veterans, we've helped power this program with the VA for years. Both of these relationships are examples how our platforms drive value for partners and importantly, provide sequencing scale for Personalis.
Before I turn it over to Aaron, to go deeper on the financials, I have a few exciting corporate updates. First, we continue to innovate and deepen our strong intellectual property position. We had two new patents recently issued by the US PTO. In fact, one just yesterday relating to the use of two of our core technologies, tumor-informed personalized assays in the first patents and boosted exome panels in the second patent each to inform cancer vaccine treatments.
This latest patent is a fourth US patent issue in 2024. And today, our number of issued US patents has over 30. We believe we have a deep set of IP, protecting our pioneering work from both MRD. and PCV. We are engaged in litigation with Foresight diagnostics to enforce and protect some of our IP relating to MRG is often the case. There will be ups and downs along the way in that journey. However, we are confident we're set up for long term success to establish an industry leading position around the use of whole genome sequencing for MRG and are optimistic about the path forward. And second, we crossed two milestones. This quarter, we processed our 400,000 samples since our company's inception. And importantly, we completed our 175th thousand whole genome sequencing sample. Whole-genome is the foundation of our NeXT Personal MRD tests. And these milestones underline both our sequencing scale and unique operational capabilities.
With that, I will now turn it over to Aaron to review our financial results.

Aaron Tachibana

Our strong first quarter 2024 financial results demonstrate our ongoing commitment to execution against our milestones and scaling revenue. I will be providing details about the first quarter financial results and guidance for the second quarter and full year of 2024. Total company revenue for the first quarter 2024 was $19.5 million and increased 4% compared to $18.9 million for the same period of the prior year. The increase in revenue was driven by higher volume from biopharma and personalized cancer vaccine customers, which was partially offset by declines from the tariffs and the VA MVP.
Biopharma revenue grew 55% as compared to the same period last year. And the growth was from immuno Idenix and also from our MRD tests ex personal, which is beginning to ramp up with many customers. In addition, we achieved a significant milestone and recognized our first clinical revenue in the amount of $0.2 million from NeXT Dx for which we receive Medicare reimbursement coverage in January of this year.
Gross margin was 20.1% for the first quarter compared to 25.1% for the same period of the prior year. The year-over-year increase of three percentage points was primarily due to favorable customer mix from the increase in biopharma revenue and also operating leverage from the increase in total company revenue.
Operating expenses were $24.4 million in the first quarter compared with $34.6 million for the same period of the prior year. Most of the year-over-year decrease was attributed to the actions taken to reduce headcount in 2023. R&D expense was $12.8 million in the first quarter compared with $16.6 million for the same period of last year.
And SG&A expense was $11.6 million compared to $14.1 million for the same period last year. Net loss for the first quarter was $13 million compared to $28.7 million for the same period of the prior year. The first quarter net loss included a $4.8 million noncash gain related to fair value accounting of the outstanding warrants issued to Tempus. The nonstandard income was a result of the decrease in fair market value of the warrants at March 31st, 2024, compared with the fair market value at the end of last quarter. And for clarification, the accounting implications for the Group earnings will have no bearing on the cash value if they are exercised in the future.
Now onto the balance sheet, we finished the first quarter with a strong balance sheet with cash and short-term investments of $95.4 million. During the quarter, we used $18.8 million to fund operations. And we have approximately two years of cash on the balance sheet, which is expected to last through the first quarter of 2026.
Now I'd like to turn to guidance for the second quarter of 2024. We expect total company revenue in the range of $19.5 million to $20.5 million revenue from pharma tests, enterprise sales and other customers in the range of $18 million to $19 million and revenue from population sequencing of approximately $1.5 million.
And for the full year of 2024, we now expect total company revenue in the range of $76 million to $78 million, an increase from the prior estimate of $73 million to $75 million. Revenue from pharma tests, enterprise sales and other customers in the range of $68 million to $70 million, which increased from the prior estimate of $65 million to $67 million. Population sequencing revenues to be approximately $8 million.
Non-GAAP net loss of approximately $77 million, which decreased from the prior estimate of $80 million, and it does not include any income or expense related to the outstanding warrants issued to Tempus. And cash usage is expected to be approximately $62 million. And we look forward to updating you on our progress during the next conference call in a few months.
And with that, I will turn the call back over to the operator and begin the Q&A session.

Question and Answer Session

Operator

(Operator Instructions) Hugo Koh, Morgan Stanley.

My team this is Madison on for you to, and congrats on the quarter. Thanks for taking the question. And just wanted to start out with the finalization of the FDA's LDT regulation. I'm just wondering if you could speak to your strategy in adhering to their requirements and what kind of implications for personnel Personalis are expecting with respect to next, the accident, personal?

Christopher Hall

Yes, awesome. Great. Thanks. Thanks for being on Madison. Yeah, the FDA issued their final guidance for regulations and an overall we perceived it to be good for the industry. Certainly good for Personalis. And we have a quality management system here that we think is super robust. We're regularly inspected by most of all the large biopharma companies we've been operating with ISO certification, New York, et cetera. And we think that what we're doing sort of fits in well with what the agency expects based on the guidance.
And so we feel like we're we're set up well and we think ultimately, it's good for us. We'll note that, you know, there were the grandfathering section around having adults to live. We have both of those tests are laboratory-developed test and are both on our both are both on the market as of the effective date of the FDA guidance. So we think that's that's good. And secondarily up because of our long relationship with New York and having New York certification, we submitted both of the tests for New York for New York approval. And so ultimately, we expect to have New York approval for both testosterone. So we think it's net-net a positive for Personalis and puts us in a good position.

Got it. Apparent that this year and then just one follow-up one with following the recent AdCom meeting to evaluate MRD and endpoint and multiple melanoma trial, just wondering, beginning with the U.S., our solid tumor space and specifically with the panel emphasizing some sensitivity, how do you see next personal position for capturing clinical trial opportunity?

Christopher Hall

I would just note, I mean, one of the one of the things. I think these two dovetail together out there is I mean, clearly what the agency did with the unanimous approval of using that multiple myeloma is blood-based.
We expect this to continue the march solid tumor. And I think that the new guidance and having the LDT and the quality management systems, et cetera, it's going to make it harder for companies that are well-funded ultimately to build to get the kind of position in the space that you would need to do. So I think it sort of works. It works together well, especially if you use if you if you appreciate that the FDA is going to integrate, we believe, at some point CTG. and A. as auditory metrics for these clinical trials doing that can allow biopharma companies to resolve ourselves sooner and ultimately speed up access to drugs for patients who are engaged with most of the most of the top biopharma companies right now that are either using the technology, assessing the technology or or are doing pilots or bake-offs.
And there's always a long sales cycle with biopharma with these with these products but the ultra sensitive nature allows them, we believe, and we're starting to see in the data that were and we're both talking about at industry on scientific gatherings and what we're starting to see in our early testing data is that we're seeing almost 40% of the positive results are in the ultra-sensitive range. And those are those are real patients that we're identifying cancer sooner and that insight and that discrimination is appealing to biopharma companies to want to have that discrimination in their clinical trials. And they want to make sure if they use a test as an entry point to actually take the drug go into two arms. We want to make sure that the patients that are most likely to recur ultimately enter the trial. And so we're getting really positive feedback on the assay and that way to panel.

Operator

Mark Massaro, BTIG.

This is Janine on for Mark. Thanks for taking the questions. First for Dr. Stein to raise to the guidance and beyond the beat and the number of offerings, some of which are newer like NeXT Personal, which might not be driving revenue out first with some more mature partnerships like Madonna. So looking to 24, just curious if there's any area in particular where you're expecting to see strength versus some product lines that might be softer base.

Aaron Tachibana

And again, this is Aaron. Thank you for the question and being on the call in terms of the guidance. So we raised guidance primarily because of the strength of biopharma demand in terms of where that strength is coming from. So immunology Nexus is holding it up very, very well. We have a lot of pharma headwinds today. But in terms of the opportunity, it's really with NeXT Personal. And we have we've done really well in the first quarter with NEXT personal and we have a tremendous funnel that's building. And we see that the growth is going to accelerate as we head through the back half of 2024 with some and next person. In addition, as Chris mentioned in the prepared remarks that we are seeing strength from the personalized cancer vaccine side of the business as well. And that's, again off of REVLIMID platform as a perfect on Yandex.

And that dovetails into my next question to the three 38 NeXT Personal test, it was great to see and how you're expecting that to ramp throughout the year after Tempus starts, marketing it as well. And just wanted to get a sense if reimbursement either has to be more of a 2025 event or if there is any updated timing there now?

Christopher Hall

I mean, our goal this year is to submit the share for all three cancer indications in I'll answer and stitch it together. And we think that the data's coming together to allow us to do that. We talked in the prepared remarks that the VHIO. and the Royal Marsden data would be featured at Asco on a podium presentation, which we think is he's great and we're tracking to be able to get the data ultimately submitted for publication published to be able to to be able to submit across the three indications for coverage in 2024, which is which is our stated goal now that's aggressive on will continue to grow the number of doctors that are in the AP. through our own efforts slowly through our own efforts and then with Tempus. And so we'll see the number of patients referred to us for NeXT Personal testing continuing to grow through the year.

Aaron Tachibana

Maybe just an add on to what Chris just articulated Viviant. So we're seeing great strength. We have a lot of demand with doctors wanting to participate in the program. Number of tests are continuing to grow, but there's a balance, we're going to be a little bit careful with how much we've taken perform tests on primarily because of reimbursement rate. But we don't want to just burn a lot of cash. We want to make sure we learn we want to ramp, but also there's cash component of it.

Christopher Hall

One of the question, yes, one of them, one of the neat things about this relative to volume growth from an investor standpoint, it's always been appealing about the MRD market is there's always an annuity right issue as you build the first baseline test you repeat test over and over time as patients sort of go through their cancer journey is continuing continued testing of personalized genetic fingerprints that you create for the patient and so we're seeing that happen. We're seeing nice growth in the repeat test of the patients that we that we that were referred to us previously, which is a really great dynamic in the space and thanks, guys.
It should be.

Operator

Dan Brennan, TD Cowen.

It's Joe on for Dan. Thanks for taking them on again, a little bit more on the 330 MRD test. What do you need to see to open that with the substitute [50 docs] that you mentioned in Q4? Is that more capacity or demand? Or is it really just holding back tests until you get more widespread reimbursement? So maybe is there like what sort of cap you're thinking about for annual volumes before you get coverage on the three times?

Christopher Hall

Yes, the latter, we're moving really slow down because of reimbursement. And one of the one of the things I think that's obvious by looking at all the progress that we made through 2023 at bringing down the burn rate of the Company, extending the cash out of the company is that we're being very thoughtful about where and how we spend the resources that we have.
And so it's really important through this journey that we build advocates for the products that we continue to build clinical evidence that we continue to learn the right way to position talk about the products and that we test the relationship with with Tempus, and we really get to the point where we feel confident that once we get reimbursement, we can pull the trigger and go super fast. But until we get reimbursement, we're not planning on going super fast because it's we don't get paid for those samples and data. We want to make sure that we're really thoughtful and doing the right thing with eight bit investors money.

Got it. And then on the burn, does the two years of cash assume or even revenue level like at or around $100 million now that you've implemented your $100 million in 2025 framework? Or is it closer to like consensus was a little bit lower?

Aaron Tachibana

Hey, Joe. Yes. So in terms of the burn, we've mentioned the cash will last through the end of the first quarter of 2026. So it does contemplate it's something that's close to that $100 million range in 2025.

Christopher Hall

And then just last on the patent, is the core IP that you're enforcing specific to whole genome sequencing and far tumor solid tumor? Or are there other key aspects of IP that and again, I mean, we're a relative relative to MRD., very broad of both MRDMPCB., very broad, both around whole genome at that, the way in which we and the way in which we do process. And then there's IP that was mentioned around the exome and the way we boost the exome it relative to its use in PCB.
And I point out I've mentioned it right, is just to underline because we spent a lot of time significant energy building the protections around what we're doing and we continue to make progress. And we've been mostly focused on driving the business really aggressively towards MR depot. But we wanted to make sure we underline that there is a deep amount of IP here that we think is building getting stronger and that we continue to work on and evolving and extending as we as we invest in R&D and so we had some success this quarter and we wanted to touch part of our ongoing journey.

Operator

Thomas Flaten, Lake Street.

Thomas Flaten

Hey, good afternoon, guys. Appreciate you taking the questions. I just wanted to clarify something with the Trade Direct collaboration, the publication that you will use for your reimbursement dossier will that be the initial as well cohort? Or will that be a publication covering the full cohort, which we expect to see a readout on later this year?

Christopher Hall

Thomas Richards is with us. So he is going to take that one fit one.

Richard Chen

Yes, the publication that will support our reimbursement will be the second publication that that entails the entire cohort so that we're targeting for kind of later this year. And the first was the publication will come out, but it's only a subset of the data that we have.

Thomas Flaten

Got it. And then, Chris, I want to make sure I didn't misunderstand what you said, but did you did you say that the material relationship could persist into 2025 or did I misunderstand that?

Christopher Hall

You said that we have a great working relationship and we're optimistic it is that it will that we will continue to work with them into 2025.

Thomas Flaten

And if I could just add and add a third one, the have you discussed with Tempus and maybe they haven't an alternate solution of adding NeXT Dx. It strikes me that being able to order both tests through one through one sales channel would make sense, but how are you thinking about those two tests working in synergy with each other long term?

Christopher Hall

Yes. So from where we are seeing NeXT Dx being ordered with NeXT Personal and our early access clients and that demand is strong. What we're seeing in the marketplace. And I think everyone is seeing in the marketplace is that the power of the MRD testing is unique differentiated and the CGP. testing physicians are seeing more in a way that they're more interchangeable. And so there are there. They're ordering as CGP. test paired with the MRD. as a convenience play, same patient same tissue, same, et cetera. And so we're certainly seeing that of Tempus as their own MRD. test. And so through the samples, not MRD test their own CGP. test, excuse me. And so they will be and then we don't be providing that. Now I'd like to do it at their customers. And so we expect the NeXT Dx our approach to only come through with the doctors that we sell ourselves.

Operator

Mike Matson, Needham.

This is Joseph on for Mike. Maybe just one on pharma demand on the obviously, as you guys said, you've seen increase in demand there. Is that mainly coming from and I guess new customers coming back in are more existing customers kind of expanding their order books, maybe there's similar customers that we've had up to now.

Aaron Tachibana

So it's not really new customers, just the expansion of the order book and the opportunity. In addition, the modernity relationship has been strong and that business has started to increase as well.

Christopher Hall

Yes. And then at the first moment, we basically have that turns into the use of immuno ID. and PCV. is really starting to accelerate as our current data enroll the patients in their clinical trials and then X personnel being a new product and the biopharma starting to grow. And so that those two things are really starting to put wins to our sales relative to finish.

Got you. And then maybe just in there for the early access program for next personal. And I guess, do you have, I guess, an engagement rate for those using NeXT Dx on then, I guess was that a full quarter that you guys kind of launched NeXT Dx AM?

Christopher Hall

Yes, yes, the NeXT Dx, we so NeXT Dx, we launched some, I would say, year and a half ago, and we kept it very, very, very small. And it was and it was used by a few physicians when we launched NeXT Personal as an LDT laboratory developed test in October. That's when we started to see next personnel being used side-by-side with or the next the next DXCGP. product be used with CMRG product side by side. And I think I mean, I'll have to check with the adoptions been wide across the entire 10 people in the EAP program. I don't know if I can say they're all done that, but certainly a significant majority. Most of them have been using NeXT Dx same time that they use X personnel.

And then just maybe one last one on for the molecular or I guess for the physicians in the quarter, I guess for the test, is there an average test per patient you guys are seeing?

Christopher Hall

I don't think we have enough time to review any more time on that path about an average tenure per patient here because I think a lot of these people are new to these, but we are starting to see the repeat testing, in fact, because when you're fixed at 10 physicians a lot of times in these hyper growth mode in these companies launches, you're also you're starting to really sign up a lot new doctors that so your V ones are always growing at a dramatic rate because you're driving or doctors in a world where we fixed the doctors, we want to launch into a rhythm of getting the clinical samples coming from those doctors.
Now we've hit the point where the repeat testing is starting to how pays but weekly new tests coming in right on just because it's starting to accelerate. So we'll we'll we'll come up with a way that we ultimately talk about that metric. But I don't think we have any insight right now? Well, relative relative to the number of tests per patient. But I think as we get a year two years in the rearview mirror, even when it starts to kind of.

Operator

Arthur He, H.C. Wainwright.

Arthur He

So I guess I just wanted to get a quick question regarding the early access program for the personal Dx of our with for this program for I know you mentioned a doctor on the waiting list at the beginning. I'm just curious, is deal is there any more doctors getting on the wellness and the game longer was closed?

Christopher Hall

Well, there was growth there. And yes, we are there is there has been growth and quote the waiting list. We just decided we're not going to track that quarter over quarter. We thought that the reported test was the best way to sort of provide to provide insight, but we are we do have a wait list and then Tempus is starting their discussions. And so we expect there to be a pent-up demand and they're creating two up separately as they engage with with customers and discussions.

Arthur He

Got you. Thanks for the additional color. And regarding the reimbursed application of you guys mentioned the aim for the I'm trying to get to the four or three indication down of this year. Besides the data package you prepared for that, what are other things you guys prepared to can increase the chance for getting the reimbursement approved?

Christopher Hall

Yes, great question. So the key thing is the data package. Now, you know, one of the one of the things that we happened to us earlier in this quarter, is that we the analytics and analytical validation data, which looked really, really strong, was published. And that is that is the backbone of every one of the submissions that's a test gives an answer across multiple cancer types out of the one part per million. It does that with really high specificity. And so that that's the backbone of every submission. Whenever you do this, the analytic validation data. And this was really strong, really robust agenda and a lot of studies, a lot of work that went into it. We're really proud of it and super excited that it got published so quickly.
So that's sort of the backbone of all three. And then we have to get up. You have to get clinical data in each one of these three. So you know, for for lung cancer, early-stage lung cancer to work with tracer X is key there with breast cancer that work with the Royal Marsden is key there because that's multiple cancer subtypes. But we're also working with Dana-Farber. We're working with MS and RA, triple-negative breast cancer patients. We have our own. We have spot clinical trial. We're doing ourselves called the stronger immunotherapy. We've got the UK data with melanoma. We've got to do data with cash, gastric patients. And then we've got the large HIO. data.
And so we continue to make progress running those samples. The key thing there is that collaborators will need to write the articles and they have to submit those articles and those articles have to be ultimately be accepted for us to for us to for us to drive submissions. And so the one piece of this that is always difficult to predict is how long it takes collaborators to write particles and to submit articles and ultimately for those articles to get aren't close to be to be accepted. But we've been very focused on driving this. So that all that comes together this year, and that's been that's been our goal. And right now we're on a plan to accomplish.

Operator

This concludes our question and answer session as well as conference. Thank you for attending today's presentation. You may now disconnect.

Christopher Hall

Thanks.