11/7/2023

speaker
Operator
Conference Operator

Good day, and thank you for standing by. Welcome to the SEER third quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You'll then hear an automated message advising that your hand is raised. To withdraw your question, Please press star 11 again. Please be advised that today's conference is being recorded. I will now hand over the conference to our first speaker today, Carrie Mendeville, Investor Relations. Please go ahead.

speaker
Carrie Mendeville
Investor Relations

Thank you. Earlier today, CIRA released financial results for the quarter end of September 30th, 2023. If you've not received this news release or if you'd like to be added to the company's distribution list, please send an email to investor at seer.bio. Joining me today from SEER is Omid Farraqzad, Chief Executive Officer, President and Chair, and David Horn, Chief Financial Officer. Before we begin, I'd like to remind you that management will make statements during this call that are forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section titled Forward-Looking Statements in the press release SEER issued today. For a more complete list and description, please see the Risk Factors section of the company's quarterly report on Form 10-Q, where the quarter ended September 30, 2023, and in its other filings with the Securities and Exchange Commission. Except as required by law, SEER disclaims any intention or obligation to update or revise any financial projections or forward-looking statements whether because of new information, future events, or otherwise. This conference call contains time-sensitive information, and it's accurate only as of the live broadcast, November 7th, 2023. With that, I would like to turn the call over to Omid.

speaker
Omid Farraqzad
Chief Executive Officer, President and Chair

Thanks, Kari, and thank you, everyone, for joining us this afternoon. I will begin our call today with a review of our third quarter results, as well as the progress we're making across our core focus areas to drive growth. Then I will turn the call over to David to provide more details on our financial results. I'd like to start by thanking our incredible team for their hard work and dedication to our mission at SEER. We're pushing the boundaries and forcing an entirely new market in proteomics amidst a very challenging macroeconomic backdrop. Even in the best circumstances, developing a new market is never easy. Our team is working tirelessly to serve our customers and help them realize what is possible using the Perdograph product suite. We ended the third quarter with $4.2 million in revenue, increasing 5% year-over-year, and approximately $381 million of cash, cash equivalents, and investments on our balance sheet. Given our performance year-to-date, as well as these ongoing challenges in the current microenvironment, we now anticipate coming in at the lower half of our revenue guidance range of 16 million to 18 million. On our last earning calls, we outlined some of the challenges that are impacting near-term adoption of our technology, as well as the actions we're taking to mitigate them. First, making it easier to access mass spec-based proteomic data. For proteomics or mass spec expert customers, we introduced a strategic instrument placement program, or SIP, to enable immediate access to the proteograph and help generate the data needed to secure funding and sample to conduct larger subsequent studies. For biologists and genomicists customers, we introduced the SEER Technology Access Center, or STAC, to enable access to a simple to conduct the first study and apply the biological insight provided by the photograph. This will accelerate publication and help researchers to secure funding for future studies and investment in bringing in workflow in-house. In addition, building market awareness and continuing to lay the groundwork for market adoption with more substantial market development efforts designed to shorten the sales cycle and enable more data to become publicly accessible. We're increasing market education with expanded outreach events, and we're supporting potential customers with proof of principle studies and examples of use cases with our application lab. We're making progress across these efforts, and I'll share more details on each throughout the call today. We have shown, along with very early customer data, that deep unbiased proteomics at scale is possible and we're forging a path forward with the broader research community. More papers are being submitted and published from our partners and customers with exciting data as well as great interest in STAC and our recently launched Protograph XD Asset Kit. I have strong conviction in the unique benefits of our technology and the differentiated insights that we offer to the OMICS customers. I remain convinced that once third-party data becomes increasingly accessible to our broader research community, our market development efforts will pay off and we will see an inflection point in adoption, the size of studies, and ultimately revenue. We're making strong progress here despite market headwinds. That said, this has been a year of learning and adopting as we change the status quo of proteomics research. We're constantly refining our approach as we figure out how to advance adoption of deep unbiased proteomics at scale. While I'm confident this will happen, it will take time, particularly in this challenging macro environment. In the near term, we continue to focus on our key critical areas to develop our business. First, enabling breakthrough discoveries with the Proteograv product suite. Second, demonstrating the power of our technology. And third, catalyzing innovation. new applications, and markets. Starting with our first objective of increasing the availability of public data and publications to validate the value of the photograph, we're aware of 180 public presentations and 48 posters of presentations by customers. This has also been an exciting year for publications, with six manuscripts submitted to preprint servers to date, and line of sites to another half a dozen that have been or will be submitted to peer review this quarter, the vast majority to high-impact journals. These publications cover a range of applications, including analyzing PQTLs, understanding the body's response to spaceflight, finding new biomarkers, signatures of Bakken disease, and validating the quantitative and precise data enabled by the proteograph. In October, two new papers were added to BioRxiv. First, researchers from Auburn University published a second manuscript using the proteograph, following an earlier one in June. They're using skeletal muscle samples to understand molecular signatures affected by aging and resistance training. finding a set of proteins in cellular senescence pathways that were upregulated over 100-fold following resistance training. Second, researchers from Brigham and Women's Hospital, in partnership with WeDiagnostics, have developed and validated three distinct measures of biological age in a manuscript now available on BioRxiv. These researchers have developed a robust Predictive biological aging phenotype, which combined with DNA methylation and multiomics, generated two biomarkers. Both biomarkers demonstrated strong association with chronic disease and mortality, outperforming current biomarkers across their discovery and validation cohorts. Additionally, these biomarkers provide opportunity to identify clinically relevant interconnections central to the aging process. This quarter, Prognomic presented exciting data from their case-controlled lung cancer cohort, demonstrating unprecedented early detection performance using a multi-omics approach, which includes the proteograph for non-small cell lung cancer. Using two different subsets presented at the 2023 World Conference on Lung Cancer and CHEST annual meeting, they highlighted validation data showing significantly higher sensitivity and specificity to detect lung cancer, particularly for early-stage lung cancer than previously shown in presentations or published data. The results of these datasets show the proteograph helped to identify 4,440 proteins and over 30,000 unique peptides on average per subject. Previously published plasma proteomics studies that included over 500 subjects have typically detected fewer than 600 proteins on average per subject. These presentations reflect the first customer data set demonstrating the value of the content that can be derived from at-scale studies using the proteograph. This is an exceptional result that could have a significant impact on discovery efforts for early detection of various diseases. We believe this encouraging and pivotal data will serve as the foundation for the development of multi-omics assay for blood-based liquid biopsies for the early detection of lung cancer. The data from this large cohort has been analyzed and is being prepared for manuscript submission. In a recent webinar hosted by GenomeWeb, Dr. Nate Bassisti from the National Institute of Aging, NIA, discussed data on a 900-sample longitudinal mouse biomarker study that they completed within just four months using the Protograph product suite. Dr. Bassisti and his team achieved deep quantitative proteomic profiling of low-volume mouse serum encompassing over 4,300 total protein IDs and revealing major alteration in lipoprotein and triglycerol-associated pathways with age and varying by mouse strain. This demonstrated both the scalability and flexibility of the proteograph to enable a species agnostic unbiased study and scale. We expect a manuscript will be coming out in the coming months. Last week, we announced that Panel Bio, a world-class metabolomics service provider with mass spec expertise has joined our Centers of Excellence program. By combining deep proteomic insights at the peptide level with the proprietary metabolomics workflow, PanOnBio will enable first-in-their-kind studies with robust pathway analysis to significantly advance research in biomarker discovery and drug development. As we focus on expanding access and resolving pain points to accelerate adoption, there is mounting interest in deep unbiased and scalable proteomics and an appetite for the publications demonstrating these results. As potential customers consume this groundbreaking data and capabilities, I'm confident that we will see these adoption momentum accelerate. Turning our attention to our second objective, demonstrating the power of the Proteograph product suite, we continue to expand the capabilities of our technology and increase access to the Proteograph via a number of initiatives. Back in June, we launched our second product, the Proteograph XC Assay Kit, which enables nearly any lab to take large-scale proteomics with higher throughput and depth of plasma proteome coverage. This product enables the analysis of 10,000 samples per year with one proteograph XT and two mass spectrometers. We're seeing good traction with XT, and it's performing exceptionally well in the hands of customers. We're on track to have the majority of our installed base upgraded to the XT configuration of the instrument by the end of this year. The power of the Proteograph XT assay was exemplified through the fantastic data that Thermo Fisher presented at ASMS in June, showing the power of the Orbitrep Astral mass spectrometer in combination with the Proteograph XT. Our partnership with Thermo Fisher to launch the SEER Technology Access Center stack has been generating a lot of interest and has had a significant impact on access to mass spec readout, giving us confidence that this was the right strategy to help open up the market. We're expecting to run thousands of samples by the end of this year with a backlog of projects. We believe that as customers gain access to, validate, and apply the biological insights provided by the prototype, this will accelerate the availability of customer data using the prototype and will increase the pace of peer-reviewed papers. In addition, over time, we believe these researchers will add MassPAC technologies to their own lab. As I mentioned, we launched a SIP earlier this year to remove the barrier of capital investment for customers. We continue to make good progress with this program and its ability to increase accessibility to our technology for those customers that would like to bring the prototype in-house. Outside of our initiatives such as SPAC and SIP, we're also working to expand our global presence through new distributed partnerships. We're partnering with Daniel Biotech in Israel and Jintika in Eastern Europe. With these partnerships, we will be well positioned to address interest from new geographies and customers around the globe. We're also making significant developments in validating our technology through two new ISO certifications received ahead of schedule. First, we received ISO 27001 certification, which helps increase our information security and cybersecurity standards. This will make us more effective with stack in our labs and collaborations and form the bridge for GDPR compliance for European customers. Second, we received ISO 13485 certification, which establishes the processes, people, and systems for quality management. This lays the groundwork for the creation of the highest quality, reliable solutions and enable the utilization of our products in FDA submissions. These certifications underscore our dedication to ensuring quality and security and pave the way for technology to make a meaningful impact in clinical settings. It is a testament to the dedication and hard work of our entire team that we achieved these significant certifications in such a timely manner. In addition to these certifications, we're making our software easier to use to make it simple for new customers to add unbiased fluidomics data to their studies. And lastly, an update on our third objective, catalyzing new applications and markets. As I mentioned earlier, the ProteoGraph is an inherently extensible technology. We have seen this time and time again across new cases in our application lab and in diverse stack projects. Our technology is being used to support the development of early detection tests, biomarker discovery, veterinary applications, and aging research. To date, we have shown use cases for skeletal muscle, host cell proteins, various model organisms, secretome and conditioned media, and low sample volume. We're working on samples to study exomes, brain, dry blood spots, tears, horse, and joint fluid. It is very exciting to see how people are imagining what they can do with deep unbiased proteomics being more accessible. I am pleased with the progress we have made this quarter to address our near-term challenges to commercial adoption. However, we still have a lot of work to do. We are actively pursuing market development activities and raising awareness about the capabilities of the Protograph product suite. More data publications and proof are emerging, revealing high-impact biological insights. Each of these studies further demonstrates what's possible and paves the way for future customers to add deep unbiased proteomics to their studies. I'm confident in this substantial long-term opportunity ahead of us. With that, I will now turn the call over to David.

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