Personalis, Inc.

All participants will be in a listen-only mode. And should you need any assistance, please signal a conference specialist by pressing the star key followed by zero. After today's prepared remarks, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touchtone phone. And to withdraw a question, please press star, then two. Please also note that this event is being recorded today. I would now like to turn the conference over to Carolyn Corner, Investor Relations. Please go ahead.

Thank you, Operator. Welcome to Person Analysis Third Quarter 2023 Earnings Call. Joining today's call are Chris Hall, Chief Executive Officer and President, and 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, 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, the outcome of legal proceedings to enforce patents, the validity or enforceability of our patents, and our market opportunity 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 SEC, including the risk factors described in our most recent quarterly report on Form 10-Q. Personalis undertakes no obligation to update these statements, except as required by applicable law. Our press release for the third quarter 2023 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 on third quarter business highlights.

Thank you, Caroline. Good afternoon, everyone, and thank you for joining us. We're thrilled with the progress we made since we updated you in August. We exceeded our revenue goals for the third quarter and increased our full-year guidance. We presented compelling data on Next Personal with the team at TracerX. We launched the next personal clinical test. We deepened our collaborators in breast cancer, and we strengthened our management team. I'm very proud of the team and personnel for delivering on the commitments we've made to investors and our continued focus to execute our win in MRD strategy and establish Next Personal as the centerpiece of a better management paradigm for cancer patients. Let's start with our commercial traction. As mentioned in our press release, We reported $18.2 million in quarterly revenue powered by NICE growth in each of our business lines, biopharma, enterprise sales including Natera, and population sequencing for the VA MVP. That performance represents 23% year-over-year growth. I'd like to point out that we've managed this growth despite an environment where biopharma companies have been cutting their spending on clinical trials and related services. and the actions we took earlier this year to streamline and remove non-profitable business. Given our commercial traction, we're raising our guidance to 73 to 74 million. Now, while our revenue goal in Q3 exceeded our goals and allowed us to increase guidance, we're most excited about the progress we're making in executing our win in MRD strategy. MRD testing, using liquid biopsy tests to find residual or recurrent cancer and to monitor treatment effectiveness, is expected to grow into a $20 billion plus market. As a reminder, our Win an MRD strategy has four pillars. First, focus and launch our test in cancer types where an ultra-sensitive liquid biopsy test can unlock significant value for patients, payers, and partners. Second, to drive reimbursement by developing robust clinical evidence and partnering with the top global collaborators. Third, to commercialize Next Personal with a partner-centric model, and fourth, to leverage our deep biopharma relationships to power the development of clinical evidence by the use of Next Personal in clinical trials. I'll next review each of these strategies and the progress we've made this quarter. First, starting with indications for ultra-sensitive tests. We've chosen to focus on early-stage lung cancer, breast cancer, and immunotherapy monitoring because a high-sensitivity test is uniquely to detect recurrence very early and to guide treatment decisions and to de-escalate low-risk patients off of therapy. Let me elaborate about high sensitivity and why that matters for our key indications, as it's at the heart of our strategy. We detect cancer at levels down to one part per million. What this means is the next personal may find residual or recurrent disease when there is only as few as one circulating cancer DNA fragment among a billion normal DNA fragments in the blood, allowing our test and platenform to detect cancer earlier than competitive technology. And it can do this not just for some patients, but consistently for most patients across many different cancer types and stages. We believe NexPersonal can provide confidence that one, when we detect cancer, we see it earlier, When patient management can be modified to result in more favorable outcomes, and two, when we don't see cancer, the patient will likely remain disease-free and may not need additional therapy. In early lung cancer and some types of breast cancer, our approach is particularly well-suited to escalate and de-escalate therapy. Detecting the cancer recurrence early may be the key to getting a patient the therapy they need to save their lives, and next, personal sensitivity may be key to identifying patients with low risk of recurrence so they can potentially avoid additional treatments. We've kicked off our commercial journey by launching our next personal test for early access clients. We've confirmed this quarter the next personal can detect cancer as low as one part per million, and we've completed the analytical studies and documentation needed to launch the test. The launch has been met with robust early demand with several doctors sending us samples. We continue to deepen the clinical evidence of our test with early adopters and expect to ramp up rapidly post-Medicare coverage. As a reminder, we're managing towards obtaining Medicare coverage in late 2024. The second part of our win in MRD strategy is to develop clinical evidence with top institutions and thought leaders around the world to demonstrate the clinical validity and utility of our test. In early stage lung cancer, we're working with the Tracerx Consortium led by lung cancer expert Dr. Charles Swan and teams at Cancer Research UK the Francis Crick Institute, and University College London. Previously, this group conducted research on prior generations of MRD assays and identified significant opportunities for detection improvement and is now using NexPersonal to determine the clinical value of an ultra-sensitive assay for early stage lung cancer. The TRACERx team presented compelling clinical evidence at ESMO a couple of weeks ago highlighting the power of the NexPersonal assay. There were three key findings. We are seeing higher sensitivity, up to four times higher, than other liquid biopsy tests analyzed by tracerX. Second, we found lung cancer six to 11 months ahead of standard imaging and significantly ahead of other tests. And third, we have the ability to determine low and high recurrence risk, which could lead to improved therapy decisions. We expect the complete cohort results from the tracerX study to be published in mid-2024. In breast cancer, We're actively processing samples from our Royal Marston collaboration. Royal Marston is one of the leading global institutions in breast cancer, and our work is focusing on patients with early stage disease for several subtypes, including ER positive, HER2 positive, and triple negative breast cancer. The Royal Marston collaboration provides us access to a well-annotated set of samples with no clinical outcomes. We plan to use our work here to provide a clinical data set to support our medical coverage in breast cancer. The data set is expected to be showcased in mid-2024. Excitingly, we recently added two new collaborators in breast cancer to augment our path for Medicare coverage. First, we're now working with Dana-Farber in breast cancer, which provides us a robust set of HER2 prospectively gathered samples, and also the Institut Carre, which gives us access to a study that was a prospectively gathered triple negative breast cancer patients. These are extremely important because we now have multiple prospective cohorts that we can leverage to drive both commercial success and underpin our reimbursement submission. Additionally, for breast cancer, we have our own prospective clinical trial called Be Stronger, and it has begun. We made progress establishing committed sites and are targeting to begin enrolling patients late this year. For IO therapy monitoring, we have multiple collaborations underway. Our key study is a pan-cancer data set with Valdeheberon Institute of Oncology, VHIO. designed to demonstrate and leverage the efficacy of Next Personal for IO therapy monitoring. VHIO gives us access to a large, well-annotated bank of prospectively gathered samples that are the cornerstone of our efforts to achieve reimbursement coverage for pan-cancer IO therapy monitoring. We have begun testing VHIO patient samples, and we expect to present clinical data next year. This is an exciting collaboration, and it joins existing work we've announced on melanoma and IO therapy with the University Medical Center Hamburg-Eppendorf, also known as UKE, and also our Duke relationship. We're driving hard to process all the samples across these many collaborations and expect collaborators and investigators to report data through 2024 and to be able to submit this data into multiple publications. With all this data gathered, we plan to submit for reimbursement coverage in all three cancer types next year. and we're targeting to achieve coverage for at least one of them in 2024. The third part of our strategy is a unique partner-centric path towards commercialization. We're seeking partnerships that help us amplify our message to the marketplace, helping us market and sell our test in a capital-efficient manner. We continue to work on that core part of our strategy, and we believe it provides significant opportunities to accelerate commercial traction while minimizing investment. The fourth and final part of our strategy is to leverage our biopharma relationships and establish infrastructure to submit Next Personal as the assay of choice to determine clinical trial enrollment, monitor therapy effectiveness, and develop new insights into treatment pathways. This quarter, we continue to deepen our business with pharma clients, and in particular, driving Next Personal forward in several discussions. Drawing these relationships is important to us, and in September, we announced that Ms. Deepshika Bhandari joined Personnalis is SVP regulatory quality and clinical compliance. Most recently, she was VP regulatory affairs at Grail and has also held leadership roles at Roche Diagnostics. She and her team are charting a path forward to establish our next personal assay as the clinical trial enrollment assay of choice for our pharma partners. Next person was the key driver of revenue growth moving forward. And over the last quarter, we've demonstrated strong performance for the test and one of the best data sets available globally We've deepened the list of our blue-chip collaborators, and we've launched our product. Our progress and execution on our women and MRD strategy has been impressive, but we've also made progress in other parts of the business. As we've mentioned before, our platform is powering personalized cancer therapies. As announced earlier this year, we are a key partner for Moderna's clinical trial work as they pursue regulatory approval of their personalized therapies. We are partnered with Moderna across their clinical studies, and as Merck and Moderna disclosed, they began enrolling patients in their Phase III clinical trial for melanoma. We expect this partnership to be a significant driver of revenue for us in 2024 and 2025. With thousands of new cancer patients each year in the U.S. alone, our aspirations are for personalysis technology to power the development of next-generation vaccines and therapies, as we are doing with our Moderna partnership. Lastly, turning to our population sequencing business, We recently received a new task order from the U.S. Department of Veteran Affairs Million Veterans Program, known as the VA MVP, in the amount of $7.5 million. This relationship stretches back several years, and we are proud to continue supporting the VA MVP in their initiatives. It's an exciting time at Personnel with much progress across multiple fronts, and we appreciate our collaborators, partners, and investors being part of our journey to establish an ultra-sensitive test at the forefront of the MRD market. With that, I'll now turn it over to Aaron to review our financial results for the quarter. Thank you, Chris.