Personalis, Inc. Q3 FY2024 Earnings Call

Good afternoon, everyone, and welcome to Personalis Third Quarter 2024 Earnings Conference Call. All participants are in listen-only mode. A question-and-answer session will follow the formal presentation. Please note this event is being recorded. I'd now like to turn the conference over to Mr. Caroline Corner. Please go ahead, ma'am.

Thank you, operator. Welcome to Personalis’ third quarter 2024 earnings call. Joining today’s call are Chris Hall, Chief Executive Officer and President; Aaron Tachibana, Chief Financial and Chief Operating Officer; and Rich Chen, Chief Medical Officer and EVP, R&D. All statements made on this call that do not relate to matters of historical facts should be considered forward-looking statements within the meaning of 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 third 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 P.M. Pacific Time today. Now, I would like to turn the call over to Chris for his comments and third quarter business highlights.

Thank you, Caroline. Good afternoon, everyone, and thank you for joining us for our third quarter call. For those of you joining one of our calls for the first time, welcome. Personalis is a leader in the fast-growing minimal residual disease (MRD) testing market. MRD involves using blood, commonly referred to as a liquid biopsy, instead of imaging or invasive biopsies to monitor therapy and detect cancer recurrence after treatment. The MRD market is expected to mature into a $20 billion market. With our ultrasensitive MRD assay, NeXT Personal, we believe Personalis is well-positioned for success. Our technologies are able to spot cancer when there's only one fragment of tumor DNA circulating among a million DNA fragments in the blood. Our platforms are used by many of the world's top biopharma companies to enhance clinical trial results, personalize treatment, and drive a new generation of therapies. Before we dive into our third quarter results, I want to share a recent case that highlights the power of NeXT Personal to detect residual and recurrent cancer and impact patient care. A doctor began using NeXT Personal to monitor a female patient in her 70s who had been diagnosed with Stage 1 HER2-positive breast cancer. After the patient underwent a lumpectomy and received standard adjuvant therapy, the doctor started monitoring her with NeXT Personal, conducting multiple follow-up tests over a five-month period. Each test indicated that cancer was still present, with circulating DNA tumor at a low level, between 25 and 30 parts per million, which is in the ultrasensitive range. As a reminder, the ultrasensitive range refers to measurements of circulating tumor DNA below 100 parts per million that our NeXT Personal test excels in quantifying—levels that could be missed with less sensitive tests. In this case, because the NeXT Personal test detected small traces of persistent cancer, the doctor was concerned and ordered additional imaging, which led to the discovery of another breast nodule and the initiation of radiation therapy for the patient, along with plans for additional chemotherapy. We are beginning to hear many anecdotes like this, demonstrating how our platforms are impacting clinical care. Pharma partners and oncologists are noticing and starting to adopt NeXT Personal, and this is driving the performance we experienced this quarter. Now, with that example illustrating how we're driving advancements in care, let's switch gears and dive into the quarter. Earlier this year, we outlined a strategy to scale our business with three growth engines. In the third quarter, we achieved revenue of $25.7 million, up 41% year-over-year. This improvement was driven by our biopharma business, which grew 96% year-over-year, led by strong demand for our tumor profiling product used to create personalized cancer vaccines for patients, as well as increasing demand for our MRD product, NeXT Personal. Our strong Q3 revenue also enabled us to increase our full-year guidance, and we now expect revenue in the range of $83 million to $84 million. We are particularly pleased to deliver this top-line growth while simultaneously improving our cost structure and margins, as Aaron will cover shortly. We also raised a significant amount of capital this quarter in a cost-efficient manner. Aaron will discuss the details in his section, but we raised approximately $62 million from a combination of proceeds from Tempus and from accessing the ATM program. Most of this capital went directly into our bank account, and we ended Q3 with $143.7 million in cash, which we believe takes us into the first half of 2027 and well beyond the point where we expect to achieve reimbursement for NeXT Personal. I'll now review the progress this quarter on our three growth engines. The first growth engine, Win-in-MRD, is crucial as we focus on transforming Personalis into a clinical diagnostic powerhouse. MRD testing uses a liquid biopsy to find evidence of residual disease or cancer recurrence and to monitor therapy effectiveness. We laid out our Win-in-MRD strategy back in 2023 and have been intensely focused on executing its four pillars. The first pillar emphasizes focusing on cancer types where an ultrasensitive approach can unlock significant value for patients, payers, and partners. The second pillar is to drive reimbursement by developing robust clinical evidence and partnering with top global collaborators. The third pillar is to leverage our deep relationships to accelerate adoption by biopharma partners and power our revenue growth through the use of NeXT Personal in clinical trials. Finally, the fourth pillar is to commercialize NeXT Personal with a partner-centric model. To elaborate on the first pillar, we've previously highlighted some of the evidence to support NeXT Personal's unique clinical usage and reimbursement in lung cancer, breast cancer, and immuno-oncology therapy monitoring. Our focus on these indications is intentional, as our data demonstrates that NeXT Personal can perform exceptionally well in these markets. To delve into the first pillar, lung cancer and breast cancer shed very little DNA into the blood, making it difficult to detect small traces of cancer without an ultrasensitive approach like NeXT Personal. Lung and breast cancers can be aggressive when they recur, making early detection critical. For patients undergoing immuno-oncology therapy, we believe the decisions regarding treatment switches require insights from monitoring provided by our ultrasensitive test. Data from multiple studies indicates that we can see cancer recurrence earlier, potentially enabling patients to seek treatment sooner, many months ahead of imaging, and thereby achieving better outcomes. Moreover, data suggests that patients who consistently test MRD-negative, meaning our test does not detect DNA from the tumor, face a much lower risk of recurrence. In the future, greater confidence in a negative result may allow doctors to spare patients unnecessary therapies and procedures, which could avoid toxicities and save costs for the healthcare system. In October 2023, we launched the first commercial ultrasensitive MRD test into the clinic with our early access program. We started our commercial journey with just 10 doctors and received positive feedback from those physicians, successfully generating significant demand as we move through the first half of the year. We initiated our commercial and marketing collaboration with Tempus in June, yielding strong demand and prompting us to accelerate our commercial launch. Tempus now has over 200 representatives reaching out to the nation’s oncologists. Our success has contributed to healthy quarter-over-quarter growth, delivering 945 clinical tests in the third quarter, a 68% increase from the 561 results delivered in the second quarter of this year. Physicians have provided feedback that they appreciate the increased actionability afforded by our test to inform therapy selection. We report circulating DNA in the blood down to about one part per million, and our NeXT Personal test excels at providing heightened analytic sensitivity. Approximately 35% to 40% of ctDNA-positive samples in our clinical testing have fallen within the ultrasensitive range. This represents a significant increase in actionable MRD testing, enabling physicians to identify cancer recurrence earlier and monitor therapy effectiveness with greater assurance that patients with negative ctDNA results are indeed cancer-free. One more statistic underscores the value physicians place on our approach: 98% of the physicians who ordered from us in Q3 have already placed orders with us again in Q4. The demand is high for our offerings, and doctors are generally satisfied with their experiences using NeXT Personal with their patients. Moving to our second pillar, we've previously mentioned our emphasis on building and publishing clinical evidence to gain reimbursement. We continue to collaborate with many top thought leaders worldwide, and some are deep into preparing and submitting manuscripts for publication in leading peer-reviewed oncology journals. We've summarized findings from investigators at Royal Marsden for breast cancer, VHIO for immuno-oncology therapy, and TRACERx for lung cancer. While we will not provide updates on the manuscript journey, I’m pleased to report that our breast and immuno-oncology collaborators have submitted articles to peer-reviewed journals for publication. Once this data is published, it will be a key component in our dossier for submission to Medicare for reimbursement for each indication. Although our collaborators and the target publication editors control the publication process, our discussions with them continue to reinforce our confidence in achieving reimbursement for two indications in 2025. Two of our significant studies were highlighted during the 2024 ESMO Conference in Spain. First, an update on our collaboration with the TRACERx consortium for lung cancer was presented by Charlie Swanton. The podium presentation showcased NeXT Personal's ability to detect residual cancer up to nine months prior to imaging for a significantly expanded group of patients compared to last year's presentation at ESMO, and the clinical data continued to exhibit outstanding results. The second collaboration highlighted was our VHIO collaboration for immunotherapy monitoring, which includes pan-cancer studies across 18 different cancer subtypes. This study demonstrated that NeXT Personal could potentially predict immunotherapy response in patients. I’m pleased to inform you that we are now working with 14 studies across our core indications: breast cancer, lung cancer, and immunotherapy monitoring. We have collaborations with Royal Marsden and Dana-Farber on HER2-positive patients, in addition to an early-stage triple-negative breast cancer study with the Institute Curry. We are also collaborating with Vanderbilt, John Hopkins, and others on a 180-patient study in early-stage triple-negative breast cancer and HER2-positive breast cancer, alongside an ongoing prospective study called B-STRONGER-1, which has already enrolled over 50 patients. For immunotherapy monitoring, we are collaborating with VHIO and UKE in melanoma studies, a group at Duke studying gastric cancer patients, and with UCSD on a pan-cancer immunotherapy study, as well as with the TRACERx team on a lung cancer immunotherapy study called DARWIN-2. The growing data and ongoing studies affirm our commitment to demonstrating the value of our approach and platform in patient care. The third pillar of our NeXT Personal strategy is to leverage our biopharma relationships to drive the usage of NeXT Personal in clinical trials. Customers need an ultrasensitive approach to effectively select patients for clinical trials and accurately monitor trial success. The data presented indicates that patients testing negative with our ultrasensitive assay are significantly less likely to experience recurrence. Our biopharma customers can therefore expect that these patients may not benefit from a therapeutic intervention, presenting a strong case for NeXT Personal as an optimal solution to enhance biopharma trials. Additionally, utilizing an ultrasensitive test to monitor results means detecting drug effectiveness sooner than imaging, potentially allowing drugs to reach the market more quickly over time. The value we create for biopharma clients is increasingly recognized. We are engaged with most of the world's top biopharma companies, generating excitement around our NeXT Personal test, particularly following discussions at ESMO and ASCO. We continue to expand our revenue orders from biopharma customers for MRD projects, expecting accelerated growth through 2025. Now, I'll transition to the fourth and final pillar: commercializing NeXT Personal in the clinical market using a partner-centric model. In August, we announced a new chapter in our relationship with Tempus, agreeing to accelerate our commercial activities. We began our commercial journey with an early access program in October 2023, followed by the Tempus launch at ASCO in June. Our efforts have been met with strong demand and interest in our ultrasensitive approach. As a result, in August, we collectively chose to accelerate our efforts further. Tempus’s extensive sales team is now trained on our product and engaging with oncologists. To summarize, Personalis processes samples in our lab, focuses on obtaining reimbursement, invoices health insurance companies, payers, and patients under this arrangement, and compensates Tempus a fair market value for the commercial services they provide. As part of the August expansion, Tempus exercised their warrants for $18.4 million and invested an additional $17.7 million by purchasing shares at $5.07 each. This brought the total deal value to approximately $48 million for Personalis, including $12 million in milestone payments. The partnership is thriving, and we are pleased with our progress. Our goal over the next 15 months is to position Personalis and NeXT Personal for broad clinical usage, scaled operations, and rapidly accelerating revenue following reimbursement. While we have seen success with our first growth engine, our win in the MRD strategy, we've also made progress with our second growth engine: leveraging our ImmunoID NeXT platform to deepen relationships with biopharma customers pioneering new therapies. Our biopharma business grew 94% year-over-year, demonstrating solid performance across our product portfolio. Customers primarily utilize our ImmunoID NeXT platform in two ways. First, using our platform to drive translational research and discover new biomarkers that can empower their drug development efforts. We've been collaborating with most of the top 20 global biopharmaceutical companies for years. Secondly, companies in the personalized cancer vaccine market leverage our platform to generate a molecular fingerprint of a patient's tumor, facilitating the development of personalized therapy. Notably, our partner Moderna is utilizing our platform in their mRNA individualized neoantigen therapy program. The collaboration with Moderna has been a significant revenue driver for us in 2024, with most patients now enrolled in their Phase 3 clinical trial. We anticipate that our revenue from Moderna may decline over the next quarters as they transition into new studies, but we continue to support them across multiple clinical studies and expect our relationship with Moderna to generate substantial revenue for several years to come. The third engine of our growth strategy involves growing our Personalis Insight approach as we service enterprise customers. In these relationships, partners adopt our platforms and technologies to power their solutions. For instance, Natera has leveraged our exome platform as part of their MRD product to help them scale while building in-house capacity. While they have transitioned this work in-house, we foresee winding down our partnership with Natera by the end of the fourth quarter. As we accelerate our biopharma and clinical diagnostic business, we are reallocating capacity previously designated for Natera to focus on these strategic efforts. We also continue discussions with other companies regarding potential sequencing work. Another enterprise relationship we have is with the VA, which employs our whole genome sequencing capabilities to support the Million Veteran Program, a national research initiative examining gene and health influences on veterans. We've successfully powered this program for over 10 years, and in September, the VA renewed their contract with us for another year, under a new purchase order amounting to $7.5 million expected to be fulfilled in 2025. It's been another excellent quarter, and I deeply appreciate the contributions of the Personalis team, our early NeXT Personal clients, our collaborators, and partners for their work, guidance, and feedback this quarter as we continually redefine the MRD market with a more sensitive approach. We are building a remarkable company that significantly impacts patient lives and aids us in the fight against cancer. With that, I will now turn the call over to Aaron to review our financial results.

Thank you, Chris. Total company revenue for the third quarter of 2024 was $25.7 million, representing a 41% increase compared with $18.2 million for the same period of the prior year. The increase in revenue was driven by higher volume from biopharma customers and the VA MVP, which was partially offset by the expected decline from Natera. Biopharma revenue grew 96% compared with the same period last year, primarily driven by higher ImmunoID NeXT volume from Moderna's PCV projects. Our VA MVP revenue increased by 85% compared with the same period last year as we fulfilled the remaining amount of the 2023 to 2024 task order, aligning with the VA MVP's fiscal year-end. Additionally, we recognized $0.3 million of clinical revenue from our NexTDx tumor profiling test. Our gross margin expanded to 34% in the third quarter compared with 19.1% for the same period last year. The year-over-year increase of 14.9 percentage points was primarily due to a favorable customer mix and operating leverage from increased revenue volume. Over the past year and a half, we have focused on reducing product costs, enhancing productivity, cutting lab operation expenses, and improving utilization to drive higher margins. We have made significant progress. In Q3, over 4 percentage points of our gross margin were impacted by unreimbursed clinical test costs. Excluding those costs, the gross margin would have been approximately 38%. One of our primary goals is to continue expanding gross margin, although we expect some variability from quarter to quarter along the way. Operating expenses were $23.1 million in the third quarter, compared to $34.3 million in the same period last year. The decrease was mainly due to actions taken to reduce headcount in 2023 and a facility impairment charge of $5.6 million from the prior year. R&D expenses totaled $11.7 million in the second quarter, compared to $16.7 million last year, while SG&A expenses were $11.4 million compared with $12 million the same period last year. The net loss for Q3 was $39.1 million compared to $29.1 million for the same period last year. The Q3 net loss included $26 million in non-cash expenses related to fair value accounting for the warrants exercised by Tempus. This non-standard expense resulted from the increase in fair market value of the warrants at exercise compared to the end of the last quarter but did not affect the cash value or amount received from Tempus. Now, regarding the balance sheet, we ended the third quarter with a strong position, showing cash and short-term investments of $143.7 million. During the quarter, we received financing proceeds of $62.2 million net of expenses, driven by Tempus exercising their warrants, purchasing an additional $16.6 million of common stock, and selling $27.2 million of common stock under the ATM program. We utilized approximately $6 million to fund operations in the third quarter, and we have around 2.5 years of cash remaining, projected to extend into the first half of 2027. Moving on to guidance for Q4 2024, we expect total company revenue in the range of $15 million to $16 million, with revenue generated exclusively from pharma tests, enterprise sales, and other customers. I'd like to provide some context around the fourth quarter guidance and the anticipated sequential decline. Throughout 2024, revenue from Moderna accelerated due to increased patient volume in their melanoma Phase III clinical trial. As most patient enrollment has now been completed, we foresee revenue from Moderna declining by 55% to 60% in Q4 sequentially from $8.5 million in Q3. We remain committed to the long-term PCV opportunity with Moderna, who have been our partners for several years. Secondly, we previously indicated that revenue from Natera would decline in the latter half of 2024. We currently project approximately $2 million to $3 million for Natera in Q4 as we wind down our project, with no substantial revenue expected from them in 2025. Lastly, regarding the VA MVP, in Q3, we recognized $4.4 million of revenue from the 2023 to 2024 task order, which needed to be fulfilled by the end of September, coinciding with their fiscal year-end. The new $7.5 million task order we recently received is valid from October 2024 to September 2025, and we expect to fulfill this order between the first and third quarters of 2025. For the full year of 2024, we have raised our guidance and now expect total company revenue in the range of $83 million to $84 million, up from our previous guidance of $79 million to $81 million. Revenue from pharma tests, enterprise sales, and other customers is anticipated to be in the range of $76 million to $77 million, an improvement from our prior guidance of $71 million to $73 million, which includes roughly $24 million from Natera. Population sequencing revenue from the VA MVP is projected to be around $7 million, down from our previous guidance of $8 million. The expected net loss is approximately $85 million, including non-cash expenses of about $18 million associated with warrants exercised by Tempus. We're estimating cash usage in the range of $53 million to $55 million, reduced from our previous guidance of $60 million, with the decrease attributed to increased gross profit resulting from higher revenue and expense control. We eagerly anticipate updating you on our progress during our upcoming conference call in a few months. With that, I will turn the call back to the operator to begin the Q&A session.

Thank you. We will now be conducting the question-and-answer session. Our first question comes from Yoko Kou of Morgan Stanley. Please go ahead. Thank you.

Sheena for Yuko. Thanks for taking the question and congrats on the quarter. To start off, we're now almost six months post-launch for NeXT Personal, and it seems to have gained a lot of positive traction. With the expansion of the Tempus agreement, I understand you increased the volume of patient samples for NeXT Personal that you would accept. Could you talk about the rationale behind this decision ahead of potentially getting reimbursement and how you're balancing the volume ramp in anticipation of getting paid?

Yes, thanks for the question. The product has been very well-received. Initially, we started with just a handful of Tempus representatives, wanting to position ourselves favorably for when we anticipate we get reimbursement in 2025. We aimed to have a solid number of trained representatives out there working with the product and learning to share its value effectively. The expansion of the agreement allows us to have more representatives engaged and enables Tempus to better integrate our offering into their dialogue with various stakeholders. We believe this is beneficial for our shareholders as it positions us for explosive revenue growth post-reimbursement compared to starting out more slowly. We are being deliberate in our approach as we proceed with this initiative.

In addition to what Chris just explained, that was also the basis for Tempus exercising their warrants for $18 million in the quarter, alongside an additional investment of 3.5 million shares at $5.07 each. We recognize that reimbursement isn't in place yet, so we needed more capital to facilitate this growth.

Okay, that makes sense. One other question—how are you thinking about gross margin movement as we enter 2025 along with the ramp in volumes from NeXT Personal? What are the key levers you consider to improve gross margin next year?

Great question. While we haven't provided formal guidance for 2025 yet, we will share that on our fourth quarter and full year call early next year. For 2024, expect our gross margin to be in the 31% to 32% range based on where we exited Q3 and what we’re estimating for Q4. We can confirm that we have faced headwinds of about 4% to 5% gross margin points due to unreimbursed test costs, and this could increase in 2025 primarily driven by rising volumes. Therefore, gross margin could see headwinds of between 15% to 18% in terms of percentage points. While we expect our gross margins to grow in other areas, we need to address these headwinds simultaneously. Exact metrics will be clarified in early 2025.

Got it. Okay, thanks for that.

Sure, thank you.

Our next question comes from Dan Brennan of TD Cowen.

Hey, this is Joe on for Dan. Thanks for the question. It seems to be some really great momentum in MRD. But I saw in the filing that revenue from Moderna increased from 26% to 33% of total sales quarter-over-quarter, translating to around 45% sequential revenue growth. So, did MRD or CGP revenues also increase sequentially? And is there an opportunity for these revenues to grow prior to your first Medicare approvals?

Great question, Joe. Moderna indeed accelerated revenue growth in Q3, and our ImmunoID NeXT platform and MRD with biopharma clients also saw increases. However, Moderna’s growth made a larger impact on the biopharma line overall. We did recognize over $300,000 from our CGP NeXT Dx test from Medicare, which also contributed to our revenues.

Additionally, MRD revenue from biopharma companies is starting to gain traction. The buying cycles in these large companies tend to be lengthy. Following the TRACERx data presentation last year and the recent data shared at ASCO surrounding breast and IO, we've built stronger interactions with biopharma. These purchasing decisions do take time, but we're making consistent progress in that context.

Got it. Great. And on the 945 molecular tests in the quarter, can you share how to think about MRD versus profiling? And I want to confirm that this is no longer just involving the 10 physicians that you started with in your early access program?

That's correct. The 945 tests were from a combination of organic growth from our small number of representatives that we allowed in from the waitlist, and Tempus is expanding that number as well. A substantial amount of that growth stemmed from the MRD product. We're pleased to see the successful integration of our NeXT Dx CGP paired with the MRD test, as customers are looking for a one-stop shop for solutions.

Is that helpful, Joe?

Yes, thank you very much.

Our next question comes from Mark Massaro of BTIG. Please go ahead.

Hey guys. Congrats on a good quarter. Thanks for taking my questions. My apologies if you covered this; some of us are jumping between multiple calls, but I would love to hear your insights on how NeXT Personal is being received in the market compared to other MRD tests available. I'm curious if the ultrasensitive range resonated with medical professionals and how much education is required for understand these benefits?

Yes, I think that's key. We've made efforts to simplify the message. As results from physicians have shown, they frequently detect 30-40% of results within the ultrasensitive range, which has been well received. This capability to identify previously unnoticed traces of cancer has significantly driven customer retention. Our retention rate is over 90%, indicating that physicians regularly reorder. This positions us positively in the market. Would you like to add anything, Rich?

I believe you’ve articulated that well. The ultrasensitive concept has resonated with physicians because they see low-level detections that would have been missed by less sensitive tests. Many have experienced situations where initial tests were negative, only to later confirm positives.

Absolutely. We have numerous cases illustrating this, such as the patient I mentioned earlier who, despite a low-level detection, was successfully flagged for further imaging and treatment. This exemplifies our value proposition effectively without needing excessive education. We are strategically targeting physicians across different experience levels with MRD testing, ensuring we reach those who have extensive experience as well as newcomers. This multi-faceted approach will push Personalis to drive substantial progress in the MRD market.

So with the impressive growth of 68% sequentially in 945 molecular tests, which was around 66% in Q2, was this merely coincidental, or have you been intentionally holding back commercial efforts until you secure reimbursement, similar to other precision oncology labs? Also, how will you prioritize your internal resources once that reimbursement comes in?

It’s fair to say that we've held back somewhat. We still have a waitlist of doctors. We're not pushing aggressively across the entire board. While we've accelerated efforts with Tempus, we’ve been intentional in our approach. Once we secure reimbursement, we will expand our sales team to not only drive growth for Personalis but also collaborate with Tempus effectively. At present, we’re learning how to scale; while achieving 60% quarter-over-quarter growth, we need to ensure we can efficiently process samples, fulfill lead-time commitments, and fortify customer care as we build our business from the ground up.

Okay great. It's encouraging to see the extra funds coming in through various channels. Could you provide clarity on your spending strategy for 2025 now that your balance sheet appears more solid? Walk us through your thoughts on commercial organization and how you'll prioritize that in light of upcoming reimbursements?

It's worth noting our focus on cash conservation that we intend to maintain until we reach cash breakeven. We aim to carefully scale as we ensure the company functions smoothly. Concurrently, we are conscious of the ongoing efforts by Tempus, which considerably aids our commercial traction without unnecessary expenditure.

One thing to consider in our capital allocation is that around one-third of our R&D budget, approximately $50 million to $55 million annually, supports generating clinical evidence. We will sustain this funding level as we enter 2025, with potential increases in 2026 to continue pursuing reimbursement opportunities with private payers.

Yes, we will consistently push for clinical evidence demonstrating the value of ultrasensitive testing. No prospective clinical utility studies will be launched without suitable proof gathered beforehand, but we’ve got that planned within our models. Our investors should feel encouraged by this strategy.

Thank you, guys.

Thank you, Mark.

Thank you, Mark.

Our next question comes from Thomas Flaten of Lake Street Capital. Please go ahead.

Good afternoon, guys. Great quarter. Congrats. Chris, in your prepared remarks, you mentioned that breast and immunology-related data had been submitted for peer-reviewed publications. Should we then extend that to assume these will be the two indications you’re targeting for 2025 reimbursement, or is there a chance for lung to leapfrog one?

No, we’re equally focused on all three. We aim to achieve reimbursement for all three. We're planning for that internally, and while breast and immunology-related insights may be gaining speed, lung cancer also has robust data supporting it that could easily catch up. It's prudent to maintain expectations for all three.

With the Merck-Moderna melanoma study nearly completed, do you have a sense of when other studies might ramp up and how that might affect your $100 million aspirational target for 2025?

We set that $100 million target knowing that melanoma would be largely finished this year. We're committed to hitting that goal. While we haven’t guided specifically for next year, we’re working towards $100 million with various studies, including recently announced Phase III lung trials that Moderna is pushing forward. Our relationship with Moderna remains strong and will continue to be a significant driver for us.

Thank you for taking my questions.

Thank you, Thomas.

Hi guys. It's Joseph on for Mike. I understand it's early for NeXT Personal and the Tempus partnership. But have you noticed whether breast, lung, or IO has been a predominant driver of volume? Also, has there been a robust dataset like TRACER that physicians or contacts refer to when considering NeXT Personal?

We’re seeing demand across all three indications. However, it’s fair to say that immuno-oncology monitoring is a primary driver, given its pan-cancer applications. This aligns with the prevalent usage of molecular diagnostics. That said, we have witnessed robust interest in our offerings for breast and lung cancer. We effectively address problems physicians face regarding patient care and the associated insights are valuable, driving usage. All data sets have been well-received, particularly TRACERx and Royal Marsden, which illustrate early detection capabilities that outpace imaging significantly.

Thank you. One more question, Aaron mentioned ongoing discussions with other potential companies for additional sequencing. What type of contract or scope would be necessary to potentially shift focus away from MRD, which is your main strategy?

Great question. Competing in the MRD arena is our biggest focus. Any potential partnership would have to be minimally distracting in terms of our core services. We'd need agreements centered on areas where we seem best-suited, which could be our existing service offerings to ensure efficiency.

Okay. That's all from our end. Congrats on the quarter.

Thank you.

This concludes the question-and-answer session. Thank you for attending, and you may now disconnect your lines.