Personalis, Inc.

Good afternoon and welcome to the Personale's Third Quarter 2025 Earnings Conference. All participants will be in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please key in star and then zero on your telephone keypad. Please note that this event is being recorded. I will now hand it over to Caroline Corder, of Investor Relations. Please go ahead.

Thank you, Operator. Welcome to PersonAlysis Third Quarter 2025 Earnings Call. Joining today's call are Chris Hall, Chief Executive Officer and President, Erin Toshibana, 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 fact should be considered forward-looking statements within the meaning of the U.S. security laws. For example, any statements regarding trends and expectations for our financial performance this year and longer term, cash runway and liquidity position, revenue expectations and timing, size and booking of orders, products, services, technology, expansion of clinical volume, reimbursement goals, the outcome and timing of reimbursement decisions, expectations for existing and future collaboration activities, cost expectations, market size, and 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 recent filings, including the risk factors described in our most recent filings. Personnelis undertakes no obligation to update these statements, except as required by applicable law. Our press release with our third quarter 2025 results is available on our website, www.personnelis.com, under the Investors section, and includes additional details about our financial results. Our website also has the 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. With that, I would like to turn the call over to Chris.

Thank you, Caroline. Good afternoon, everyone, and thank you for joining us. Q3 was another step forward in our win in MRD strategy. We delivered 4,388 clinical tests, a 26% sequential and 364% year-over-year growth, and now have 700-plus physicians ordering NexPersonal. We also submitted lung cancer for coverage, and we now have three dossiers under review by Moldex as we continue to target two coverage decisions in 2025. Our clinical evidence from recent Phase III programs and the CATE trial launch shows how ultrasensitivity can detect progression several months before imaging and provide greater confidence in a negative result. While biopharma project timing continues to have variability, the underlying MRD demand is strong, clinical adoption is compounding, and our cash position gives us the flexibility to execute. For those listening in for the first time, Personalis is a leading company helping partners, patients, and doctors see more in cancer samples. Our ultra-sensitive next personal test is capable of detecting approximately one single fragment of tumor DNA in a million. This is not merely an improvement, it is a clinical necessity that allows us to detect recurrence months ahead of standard imaging and provides more confidence in a negative result. The market is growing rapidly for these types of tests and is expected to mature into a 20 plus billion dollar opportunity for which we are exceptionally well positioned to command a strong share. We're also a leader supporting biopharma companies with our discriminating platform and that is used to analyze cancer tumors and identify new biomarkers. Our platforms are used to build personalized therapies and allow physicians to personalize treatment for cancer patients. Now turning to our Q3 results. We delivered $14.5 million in revenue in the quarter, which was above the high end of our estimate. Our progress this quarter is best highlighted by our clinical volume. We reported 4,388 tests this past quarter, representing a 26% decrease growth over the previous quarter. To put that in context, it's worth pausing to note we did just 945 tests in the third quarter of last year, and our performance this quarter reflects a 364% year-over-year growth. And cumulative to date, we've delivered more than 13,000 tests to help patients. We're providing an updated range for full-year revenue in the $68 to $73 million range. The uneven biopharma spending environment we discussed last quarter has persisted, creating continued variability in the timing of large project-based work. While the underlying demand for our strategic MRD offerings remain exceptionally strong, this quarter, the biopharma volatility is compounded by logistical delays we believe are unique to this quarter and are impacting the timing of samples for several large projects. This increases the variability of our Q4 biopharma revenue. As a result, we are prudently adjusting our full-year guidance to reflect these updated project timelines. This adjustment does not reflect a change in underlying demand for our technology and offerings, but rather the lumpy and unpredictable nature of our legacy translational research business. And while we manage the variability with discipline, our strategic focus remains squarely on the key drivers of long-term value, clinical adoption and reimbursement. On that front, we continue to execute strongly. We advanced our goals this quarter by submitting an additional indication for coverage lung cancer, meaning we now have three dossiers under review with Moldex. We remain confident in our data and continue to target coverage for two indications by the end of the year, though exact timing is dependent on Moldex review. Our progress this quarter is a direct result of the execution of the key pillars of our WIN and MRD strategy. Now let's walk through the updates. The first pillar is accelerating clinical adoption. The oncology community is voting with their orders. We continue to see impressive sequential growth in clinical test volumes. We now have over 700 physicians ordering Next Personal, and this growing base of physicians understands that when it comes to residual disease, ultra-sensitivity matters. Our retention is high, and the growth we are seeing is a direct result of Next Personal providing greater confidence in a negative result and the ability to detect recurrence earlier than any alternative. The clinical volume growth is the single most important leading indicator of our future high margin revenue ramp as reimbursement comes online. This momentum is being driven by our partnership with Tempus, which continues to exceed our expectations. The collaboration has been so effective that we've already achieved the primary volume target we set for the entire year. When we set our targets at the beginning of the year, our goal was to grow 30% to 40% each quarter, ending the year with around 4,800 quarterly tests. We've effectively reached that milestone a quarter early, and having achieved our goal ahead of schedule, our focus the rest of the year now shifts to responsibly scaling our operational and commercial foundation. Additionally, we're strategically expanding our in-house sales force to complement the Tempest team to ensure our we are fully prepared to capitalize on the inflection point of Medicare coverage. The second pillar is driving reimbursement and adoption through clinical evidence. We are proud of the latest Next Personal data from AstraZeneca's Phase III studies. First, in neoadjuvant lung cancer, data from the Neo-ADORA Phase III trial was presented at the World Conference on Lung Cancer that demonstrated the superiority of Next Personal in the neoadjuvant setting. Next, personal showed significantly higher baseline sensitivity for ctDNA detection compared to a leading gene mutation-based test, offering physicians a more accurate assessment of disease burden and the ability to monitor treatment response. The data also showed that our test was prognostic for outcomes across treatment arms. Second, in the adjuvant EGFR-mutated lung cancer, further data from the Phase III LORA trial was presented at ESMO, which showcase the utility of Next Personal for treatment monitoring. Our assay demonstrated a medium lead time of five months in detecting MRD progression ahead of imaging and standard expert review. Lead time is a difference maker for patients, underscoring the value of an ultra-sensitive approach for earlier intervention. These studies demonstrate how our biopharma partners are utilizing ultra-sensitive MRD testing with Next Personal to better understanding response to therapy and and their phase three studies. In addition to these results, we are excited to announce the launch of the CATE clinical trial with the Yale Cancer Center and the Translational Breast Cancer Research Consortium. This prospective multi-center trial is a step towards establishing clinical utility for ctDNA-guided treatment in high-risk, HR-positive, HER2-negative breast cancer. This study is designed to generate evidence that will help integrate Next Personal into the standard of care, empowering oncologists to move from surveillance to preemptive treatment based on our ultra-sensitive detection. The third pillar is leading with biopharma partners. Our technology offers our partners a powerful way to improve their clinical trials. The use of our Next Personal technology allows them to de-risk their pipelines, reach critical go-no-go decisions sooner, and enroll the right patients for their studies. We believe this leads to improved financial performance for our customers, submitting the value of our ultra-sensitive approach. As a result, the underlying demand for next personal and clinical trials has never been higher. We capitalize on this demand by signing two major prospective clinical trials this quarter. As mentioned before, our MRD biopharma revenue is set to grow approximately 300% year over year. As we wind up the year, Personalis is executing with precision on a winning strategy. Just two years ago, we launched Next Personal and started our journey to redefine the MRD market with an ultra-sensitive approach. We made tremendous progress in this time, having built a network of over 700 physicians and numerous collaborators and biopharma partners adopting Next Personal. I want to thank our shareholders, partners, and employees for their dedication and commitment to the mission as we redefine the standard of care for cancer patients. With that, I will turn it over to Aaron to review our financial results.