Personalis, Inc. Q1 FY2024 Earnings Call

Good day, and welcome to the Personalis First Quarter 2024 Earnings Conference Call. Please note this event is being recorded. I would now like to turn the conference over to Mr. Aaron Tachibana, please go ahead.

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 Aaron Tachibana, Chief Financial and Chief Operating Officer; and Rich Chen, 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, any 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. A recording of today's call will be available on our website by 5:00 p.m. Pacific Time today. Now, I would like to turn the call over to Chris for his comments and first quarter business highlights.

Thank you, Aaron. 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 innovative 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, we're able to spot cancer when it's only one fragment of tumor DNA circulating in 1 million DNA fragments in the blood. Our technologies are used by many of the world's top biopharma companies to improve clinical trial results by personalizing treatment and powering 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 comes with 3 underlying growth engines that are our large star, as we accelerate 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 ImmunoID platform to support the individualized neoantigen therapy market, as well as increasing demand for our MRD product mix. 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 3 growth engines driving us toward our $100 million in 2025 goal and our progress on each. The first growth engine is the most important, as we focus on turning Personalis into a clinical diagnostic powerhouse. To do that, we're executing on our win and MRD strategy. The MRD 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 as a leader in the space. Our win and MRD strategy has 4 pillars. First, to focus and launch our tests in cancer types where an ultrasensitive liquid biopsy can unlock significant value for patients, payers, and partners; second, to drive reimbursement by developing robust clinical evidence and partnering with top global collaborators; third, leverage our deep relationships to accelerate adoption by biopharma partners, empowering our revenue growth through the use of NeXT Personal in clinical trials; and lastly, to commercialize NeXT Personal with a partner-centric model. To delve into the first pillar, we previously explained how we're developing evidence to support NeXT Personal's clinical usage and reimbursement in early-stage lung cancer, breast cancer, and immunotherapy monitoring. We believe our ultrasensitive technology allows us to detect cancer earlier, which may provide the information to deescalate patients from unnecessary treatments and procedures, potentially sparing patients from toxicity and saving healthcare costs. Importantly, we believe we can identify and send recurrent patients for treatment earlier, potentially resulting in better outcomes. Our focus on these indications is intentional, and our data has shown that NeXT Personal can win in these markets. To elaborate on our approach, early-stage lung cancer and breast cancer shed very little DNA into the blood, making them difficult to detect without an ultrasensitive approach. Early detection is critical in these cases. For patients on immunotherapy, we believe the potential decision to switch treatment requires the insights provided by ultrasensitive tests. Now, you might recall that last October, we launched our MRD test NeXT Personal. Today, we are enrolling physicians in an early access program. We are the first ultrasensitive MRD test to commercially enter the market. With that launch, we now have 2 laboratory-developed tests on the market, the other being our Medicare reimbursed test NeXT Dx, which is used by physicians to put a patient on targeted therapy. The adoption of these tests has been ramping and exceeds our initial targets. We delivered 338 clinical tests in the first quarter, a solid increase from the 126 tests delivered in the fourth quarter of last year. We're pleased with this traction as the number of physicians ordering in Q1 remained fixed at 10 throughout the quarter. There are 2 key metrics I want to discuss. First, all 10 of our early access positions are ordering, and uptake has been strong across the entire cohort. Second, regarding the actionability of our NeXT Personal MRD test in the clinic, if you remember, we report circulating tumor DNA in the blood down to 1 part per million, meaning if there is just one fragment of tumor DNA circulating among 1 million DNA fragments in the blood, we expect to see and quantify it. This is a major advancement for the field. The extra sensitivity we report on with our NeXT Personal assay, which has values between 10 and 100 parts per million, captures a range that has previously been challenging to consistently detect. We call that the ultrasensitive MRD range. Prior to NeXT Personal, clinicians could not routinely detect cancer recurrence at that level, and today, they can. About 40% of the ctDNA-positive samples tested thus far have been in this ultrasensitive range, indicating a significant increase in the performance of MRD testing. This means that physicians can detect cancer recurrence earlier, have more precision in monitoring therapy, and are more confident that ctDNA patients who test negative are likely cancer-free. We’ve received numerous anecdotes from our 10 early access doctors about how the ultrasensitive range allows them to detect cancer earlier, providing timely intervention. We believe it is this ultrasensitive range that enables doctors to see cancer sooner, which is fundamental to our win in MRD strategy. Now, moving to the second pillar, we are focused on building and publishing clinical evidence to gain reimbursement and are collaborating with many of the world's leading experts. In previous calls, we've mentioned our work with Royal Marsden in breast cancer and BHIO in immunotherapy monitoring. Both collaborators provide access to comprehensive studies. In the case of Royal Marsden, we are focusing on patients with early-stage disease across several subtypes, including ER positive, HER2 positive, and triple-negative breast cancer. For BHIO, our work spans various cancer types and stages. These studies are pivotal and will form the foundation of our efforts to secure Medicare reimbursement. Royal Marsden for early-stage breast cancer and BHIO for immunotherapy monitoring. We're excited to have the work with both collaborators featured at the upcoming ASCO conference in oral podium presentations. We also have 3 other studies being presented at ASCO: one with Dana Pharma on HER2-positive patients, another with Duke on immunotherapy monitoring for gastric patients, and lastly, one in colorectal cancer. Having this breadth of data underscores Personalis' commitment to developing comprehensive evidence to support NeXT Personal's clinical use and to expedite reimbursement. At the AACR conference in April, compelling data was presented. Our collaborators from the U.K. gave an oral podium presentation on late-stage melanoma patients, where they used NeXT Personal to monitor and detect immunotherapy response, highlighting the importance of detecting ctDNA in the ultrasensitive range. In addition, our work in collaboration with AstraZeneca on the Matrix study was presented. The Matrix abstract showed NeXT Personal achieved strong sensitivity and specificity on blinded test samples, down to the lowest levels at 2 parts per million. Subsequently, we were selected by AstraZeneca as a partner for MRD testing in their upcoming trials. We've also shared data from partners with a personalized cancer vaccine company, and our analytical validation data for NeXT Personal was published at the AACR conference. The third pillar of our NeXT Personal strategy is to leverage our biopharma relationships to drive the use of NeXT Personal in clinical trials. We are working with top biopharma companies and have generated excitement around our NeXT Personal test, most recently from discussions at AACR. Clients need an ultrasensitive approach to ensure that the most appropriate patients enter clinical trials. For instance, we believe our ultrasensitive assay means that patients testing negative are much less likely to have a recurrence, enabling biopharma clients to expect that these patients may not benefit from a therapeutic intervention, suggesting NeXT Personal could optimize biopharma trials. In the first quarter, we booked record new orders for NeXT Personal. This product has bolstered our robust Q1 financial performance, and we believe it will drive revenue moving forward. Lastly, I'll discuss the fourth and final pillar: commercializing NeXT Personal using a partner-centric model. In December, we announced our key partnership with Tempus to commercialize NeXT Personal Dx in the clinic through oncologists. To briefly summarize, we expect to leverage Tempus's capabilities through an approximate 200-person sales channel to co-commercialize NeXT Personal and drive growth. Personalis will handle sample processing in our lab, obtaining reimbursement and invoicing health insurance payers and patients, while compensating Tempus at fair market value for the commercial services they provide. Overall, this deal could be worth approximately $30 million for Personalis should all milestone payments be triggered, and if Tempus fully exercises their warrants. We expect this partnership will enable us to ramp up commercial efforts swiftly with minimal additional cash investments. We plan to launch with Tempus this quarter, expanding our early access program to include some of Tempus' clients. Our goal is to establish how to collaborate as partners, integrating our business systems and refining our messaging to oncologists to drive accelerated growth on the backside of reimbursement approval. While we've made strides with our first growth engine, our win in MRD strategy to establish NeXT Personal as a leading MRD test, we’ve also advanced our second growth engine, leveraging our ImmunoID NeXT platform to deepen relationships with biopharma customers who use the offering to develop new therapies. Our biopharma segment grew 55% year-over-year, and we saw robust performance across our product portfolio. Customers are mainly using our ImmunoID platform in two ways: first, to power translational research and discover new biomarkers and insights for their drug discovery efforts; and second, companies in the personalized cancer vaccine market use our platform to create a molecular fingerprint of a patient's tumor to facilitate personalized therapy. We previously mentioned our partnership with Moderna, with whom Moderna is utilizing our platform in their mRNA cancer program. Moderna and its partner, Merck, are enrolling patients, and our collaboration with Moderna is a significant revenue driver for us in 2024 and 2025. We have several other partners working in this space. The third engine of our growth strategy is expanding our personality and side approach as we serve enterprise customers. In these relationships, partners adopt our platforms and technologies to enhance their solutions and provide new insights to their customers. Our work with Natera involves using our sequencing platform to analyze the exome as part of their MRD product. We believe this relationship is strong and mutually beneficial, and we are optimistic it will continue into 2025. Another key enterprise relationship is with the VA, which utilizes our whole genome sequencing capabilities to power their Million Veteran Program, a national research initiative examining how genes and lifestyle affect veterans' health. We have supported this program with the VA for years. Most of these relationships exemplify how our platforms provide value for partners while also delivering sequencing scalability for Personalis. Before I turn it over to Aaron for a deeper dive into the financials, I have a few exciting corporate updates. First, we continue to innovate and enhance our strong intellectual property position. We had 2 new patents issued recently by the U.S. Patent and Trademark Office, with one issued just yesterday regarding the use of 2 of our core technologies: tumor-informed personalized assays in the first patent and boosted exome panels in the second patent, each aimed at informing cancer vaccine treatments. This latest patent is the fourth U.S. patent issued in 2024, and today, our number of issued U.S. patents has surpassed 30. We believe we have a comprehensive set of IP protecting our pioneering work on both MRD and personalized cancer vaccines. We are currently engaged in litigation with Foresight Diagnostics to enforce and protect some of our IP related to MRD. As is often the case, there will be ups and downs along that journey. However, we are confident we are positioned for long-term success in establishing an industry-leading position in the use of whole genome sequencing for MRD and remain optimistic about the road ahead. Additionally, we achieved two milestones this quarter. We processed our 400,000th sample since our company's inception, and importantly, we completed our 175,000th whole genome sequencing sample, which is foundational to our NeXT Personal MRD test. These milestones underscore both our sequencing scale and unique operational capabilities. With that, I will now turn it over to Aaron to review our financial results.

Thank you, Chris. Our strong first quarter 2024 financial results demonstrate our ongoing commitment to execution against our milestones and scaling revenue. I will provide 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 of 2024 was $19.5 million, an increase of 4% compared to $18.9 million for the same period in the prior year. This revenue growth was driven by higher volume from biopharma and personalized cancer vaccine customers, partially offset by declines from Natera and the VA MVP. Biopharma revenue grew 55% compared to the same period last year, contributed primarily by ImmunoID NeXT and the NeXT Personal MRD test, which is beginning to ramp up with many customers. Additionally, we achieved a significant milestone and recognized our first clinical revenue of $0.2 million from NeXT Dx for which we received Medicare reimbursement coverage in January this year. Gross margin was 28.1% for the first quarter, up from 25.1% in the same period last year. The year-over-year increase of 3 percentage points resulted from a favorable customer mix attributed to the growth in biopharma revenue and operational leverage from the increase in total company revenue. Operating expenses were $24.4 million in the first quarter compared to $34.6 million for the same period last year. Most of the year-over-year decrease is attributed to 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 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, down from $28.7 million for the same period last year. The first quarter net loss included a $4.8 million non-cash gain related to fair value accounting of the outstanding warrants issued to Tempus. This non-standard income resulted from the decrease in fair market value of these warrants at March 31, 2024, compared to their fair market value at the end of the last quarter. For clarification, the accounting implications for the warrants will not affect the cash value if they are exercised in the future. Now, on to the balance sheet. We finished the first quarter with a strong balance sheet, possessing cash and short-term investments of $95.4 million. During the quarter, we used $18.8 million to fund operations, and we have sufficient cash to last approximately 2 years, expected to cover through the first quarter of 2026. Now, let's 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, with revenue from pharmaceutical tests, enterprise sales, and other customers projected between $18 million and $19 million, and revenue from population sequencing of roughly $1.5 million. For the full year of 2024, we now anticipate total company revenue to be in the range of $76 million to $78 million, increasing from the prior estimate of $73 million to $75 million. Revenue from pharmaceutical tests, enterprise sales, and other customers is forecasted to be between $68 million and $70 million, which has been updated from the previous estimate of $65 million to $67 million. Population sequencing revenue is expected to be approximately $8 million; and for non-GAAP net loss, we project around $77 million, down from the previous estimate of $80 million. This projection does not include any income or expense related to the outstanding warrants issued to Tempus. Additionally, we anticipate cash usage to be approximately $62 million. We look forward to updating you on our progress at the next conference call in a few months. With that, I will turn it back to the operator to begin the Q&A session. Operator?

The first question comes from Yuko Aku with Morgan Stanley.

This is Madison on for Yuko. Congrats on the quarter. I just want to start out with the finalization of the FDA's LDT regulation. I was just wondering if you could speak to your strategy in adhering to the requirements and what kind of implications for Personalis you're expecting regarding NeXT Dx and NeXT Personal?

Yes. Awesome. Thanks for being on, Madison. Yes, the FDA issued their final guidance for regulations, and overall, we perceive it to be good for the industry, certainly good for Personalis. We have a quality management system here that we think is robust. We're regularly audited by most of the large biopharma companies. We've been operating with ISO certification, New York, etc., which aligns well with what the agency expects based on the guidance. And so, we feel confident and believe this is a net positive for us. Additionally, since we have long-standing relationships with New York, we've submitted both tests for New York approval. We expect to obtain approval for both tests also. So, we think it's a net positive for Personalis and places us in a favorable position.

And then just one follow-up question. Following the recent AdCom meeting that evaluated MRD as an endpoint in multiple melanoma trials, can you elaborate on its implications for the solid tumor space and specifically regarding the panel's enterprising sensitivity? How do you see NeXT Personal positioned to capture clinical trial opportunities?

Yes. One of the things to note is how these developments are interconnected. What the agency did with the unanimous approval of using MRD marker in multiple myeloma trials is expected to extend into the solid tumor sector. We believe the FDA will at some point integrate ctDNA as a monitoring metric for clinical trials, allowing biopharma companies to obtain results sooner and expedite patient access to drugs. We are collaborating with most of the top biopharma companies currently, evaluating our technology through pilots and bake-offs. There’s traditionally a long sales cycle with these products in biopharma, but the ultrasensitive nature of our tests has been beneficial. We are seeing almost 40% of the positive results in the ultra-sensitive range. These results allow us to identify cancer patients earlier. This insight appeals to biopharma companies aiming for precise patient targeting in trials. We've received very positive feedback about the assay's effectiveness.

The next question comes from Mark Massaro with BTIG.

This is Vivian Bais on for Mark. I just wanted to inquire about the guidance exceeding estimates. You have many offerings, some of which are newer like NeXT Personal, which might not be driving revenue as compared to some of your more mature partnerships like Moderna. Looking ahead to 2024, are there any particular areas where you expect strengths versus product lines that may be softer?

Hi, Vivian. Thank you for the question and for being on the call. We raised our guidance mainly due to the strength of biopharma demand, particularly for the ImmunoID NeXT platform, which is performing exceptionally well. Although we face some headwinds in pharma, we have a strong opportunity with NeXT Personal. We experienced significant growth in the first quarter with NeXT Personal. Our sales funnel is considerable, and we anticipate accelerated growth as we progress through 2024. Chris also mentioned that we are seeing strength from our cancer vaccine business, also fueled by our ImmunoID NeXT platform.

That dovetails into my next question. The 338 NeXT Personal tests you delivered in Q1, how are you expecting that to ramp throughout the year as Tempus starts marketing it? I wanted to understand if reimbursement for that test would be more of a 2025 event or if there is any updated timing?

No. Our goal this year is to submit for all 3 cancer indications and we believe the data are aligning that will allow us to do that. We've discussed in the prepared remarks that the studies with BHIO and Royal Marsden will be featured as podium presentations at ASCO. We’re on track to gather the necessary data to submit for coverage in 2024, which is our target goal. While that is aggressive, we will continue to grow the number of doctors referring patients for our NeXT Personal testing through our own efforts and alongside Tempus. We anticipate the number of patients referred for NeXT Personal testing to steadily grow throughout the year.

Just to add on to what Chris articulated, Vivian, we've seen robust demand with doctors wanting to participate in the program. The number of tests we are performing is continuing to grow, although we do need to be measured about how much we take in performed tests, mainly due to reimbursement considerations. We don’t want to exhaust cash resources unnecessarily. We want to ensure a measured ramp-up approach.

One of the compelling aspects of the MRD market is the recurring revenue structure. As we establish the baseline test, we can perform repeat tests over time as patients navigate their cancer journey. Continued engagement with personalized genetic fingerprinting that we've created for the patient allows us to see consistent growth in repeat testing. We are observing this dynamic unfold in our patient population.

Next question comes from Dan Brennan with TD Cohen.

Joe on behalf of Dan. I would like to discuss the 338 MRD tests. What do you need to see to open that up from the 250 docs that you mentioned in Q4? Is it more capacity or demand, or is it primarily holding back tests until you obtain more widespread reimbursement? Is there a specific annual volume cap you're considering before securing coverage for the three tests?

It’s primarily the latter; we’re proceeding cautiously because of reimbursement. Our progress through 2023 in reducing the burn rate and extending our cash runway demonstrates that we’re being highly strategic about our resource allocation. It’s critical through this process that we build advocates for the products while simultaneously developing clinical evidence and refining how we position and discuss our products, all while testing our relationship with Tempus to ensure we feel confident in scaling once we secure reimbursement. Until that reimbursement is in place, we won’t move quickly because we need to ensure we're spending investor resources wisely.

Regarding the burn rate, does the two years of cash assume revenue levels close to the $100 million target now that you've implemented your $100 million in 2025 framework, or is it closer to being conservative?

Yes, in terms of the burn, we have mentioned cash assets projected through the end of the first quarter of 2026, which does contemplate revenue levels nearing that $100 million range in 2025.

Lastly, regarding the patents, is the core IP specific to whole genome sequencing, particularly for solid tumors? Or does it encompass other key components?

In relation to MRD, it’s quite broad: both MRD and personalized cancer vaccines cover various aspects of whole genome sequencing as well as our processing techniques. There is also specific IP regarding exome enhancements that relate to its use in personalized cancer vaccines.

I want to emphasize that we have dedicated significant time and effort to building robust protections around our work. We continue to make progress in this area and aim to ensure that our core focus remains on rapidly driving our MRD business. However, we want to assure you that our intellectual property is extensive and continually evolving as we invest in research and development.

The next question comes from Thomas Flaten with Lake Street.

I want to clarify something regarding the Trace Direct collaboration. Will the publication used for your reimbursement dossier be based on the initial ESMO cohort or will it cover the full cohort, with which we expect to see results later this year?

Yes. Thank you for the question, Thomas. The publication that will support our reimbursement will be the second publication that encompasses the entire cohort, which we are targeting for later this year. The first publication will come out, but it will only cover a subset of the data we require.

And Chris, just to confirm, did you say that the Natera relationship would persist into 2025, or did I misunderstand?

No, I want to clarify that we have a strong working relationship with Natera and are optimistic about continuing our collaboration into 2025.

Additionally, have you discussed with Tempus if there is a solution for facilitating the addition of NeXT Dx? Having the ability to order both tests through one sales channel seems logical. How are you envisioning the long-term synergy of these two tests?

We are, in fact, observing NeXT Dx being ordered alongside NeXT Personal by our early access clients. There is strong demand for both. What we see in the marketplace is that the uniqueness of MRD testing allows for definite differentiation, while CGP testing appears more interchangeable now to physicians. Thus, we observe them ordering the CGP test alongside the MRD test for convenience reasons. Tempus has its MRD tests, which they will be providing to their clients, while our NeXT Dx approach will primarily be shared with doctors we engage ourselves.

The next question comes from Mike Matson with Needham.

This is Joseph Conway on behalf of Mike. I wanted to ask about pharma demand. You've mentioned you've seen an increase in demand. Is this mainly due to new customers coming in, or is it more about existing customers expanding their order books?

Mainly, we are seeing existing customers expanding their order books. It's not really about new customers at this stage; it's primarily the expansion of existing client engagement. Moreover, our relationship with Moderna remains strong, and that business is starting to gain traction as well.

Yes. In terms of the initial use case, we are seeing the ImmunoID and personalized cancer vaccine use accelerating as Moderna enrolls patients in their clinical trials. Additionally, NeXT Personal being a newer product is also beginning to gain traction in the biopharma sector.

Finally, regarding the early access program for NeXT Personal, do you have data on the engagement rate for those also using NeXT Dx? Was that a full quarter since you launched NeXT Dx?

Yes. We initially launched NeXT Dx about 1.5 years ago, but we maintained a very limited rollout initially, working with only a few physicians. Since launching NeXT Personal as a laboratory-developed test in October, we have begun to see the integration of NeXT Personal with the previously launched NeXT Dx product. Adoption has been widespread across nearly all 10 individuals in the Early Access Program. While I'm unsure if all have completed the interactions, the majority have been using both tests.

For the molecular testing in the quarter, do you have any insights on the average tests per patient being observed?

We don’t have enough time to provide significant insights on the average tests per patient at this moment. However, we are beginning to see repeat testing traffic. Since we top-lined at 10 physicians, traditionally, as companies launch, they add many new doctors. Therefore, with our fixed physician group, we’re focusing on building a continuous flow of clinical samples from this group. We’ve hit a point where repeat testing is now outpacing new weekly tests indicated, showcasing growth over time. We’re optimistic that we’ll have more comprehensive metrics to share over the upcoming two years.

The next question comes from Arthur Hi with HCW.

I have a question about the early access program for the NeXT Dx test. I noticed you mentioned a waitlist for doctors. I'm wondering if there has been any growth in demand for the waitlist or if it continues to extend.

Yes, there has been growth in the waiting list; however, we decided not to track that on a quarter-over-quarter basis. We believe that reported tests provide better insight. Nevertheless, we do have a functional waitlist, and we expect growth as Tempus engages with potential clients, creating significant pent-up demand.

Regarding the reimbursement application, could you clarify the preparations in place to improve the chances of securing approval?

Excellent question. The primary objective is to compile a robust data package. Earlier this quarter, we achieved publication of analytical validation data, which is necessary for every submission and demonstrates our capability across multiple cancer types at the critical 1 part per million detection threshold with high specificity. This data serves as the foundation for all three applications. We need to ensure that we also collect solid clinical data for each indication to reinforce our submissions, whether working with TRACERx for lung cancer, Royal Marsden for breast cancer, or other partners for immunotherapy and melanoma cases. While it’s challenging to predict, we are very focused on meeting our timeline of submission this year.

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