Talis Biomedical Corporation

Good afternoon, ladies and gentlemen, and welcome to the Tally Second Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions may follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. I would now like to turn the conference over to Ms. Emily Possett, SVP, Corporate Communications and Investor Relations. Ma'am, please go ahead.

Good afternoon, and thank you for participating in today's conference call. Joining me, we have Brian Coe, our Chief Executive Officer, Roger Moody, our Chief Financial Officer, and Doug Liu, our Chief Operating Officer. Earlier today, TALIS released financial results and business progress for the quarter ended June 30th, 2021. A copy of that press release can be accessed on the investors page of our website at talisbio.com. Before we get started, I would 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 entitled forward-looking statements in the press release TALIS issued today. For a more complete list and description, please see the risk factors section of the company's 10-Q filed with the SEC on May 13, 2021, and in its other filings with the Securities and Exchange Commission. Except as required by law, TALIS 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 is accurate only as of the live broadcast, August 10th, 2021. With that, I would like to turn the call over to Brian Coe, TALIS' Chief Executive Officer. Brian?

Thank you, Emily. Good afternoon, everyone, and thank you for joining us on our second quarter earnings call. At TALIS, our mission is to improve healthcare by empowering providers, patient and patients with access to fast, accurate, and easy to use laboratory quality diagnostic testing in point of care settings. We believe it is self-evident that actionable diagnostic results, while the patient is still present, have the potential to significantly improve health outcomes, especially for infectious diseases. The point of care business model also shifts the economics from centralized to decentralized locations which can further encourage adoption. More broadly, we believe that over time there will be a transformation away from centralized testing and that TALIS is well positioned to be one of a small number of companies that will serve this increasingly decentralized global diagnostic testing market at scale. On our last earnings call, we laid out our key strategic initiatives in the near term. These include, one, obtaining FDA emergency use authorization for our TALIS I COVID-19 test in the United States, two, building scalable manufacturing capabilities and the sales organization in preparation for commercial launch, and three, expanding TALIS I tests to additional respiratory infections as well as to women's health and sexually transmitted infections. I will now walk through an update on our progress with these objectives. Starting with obtaining authorization of our COVID-19 test, we submitted our EUA application for TALIS I on July 23rd, following the successful completion of our point of care clinical validation study. Our view of the data we submitted is very positive, and the results on clinical specimens exceed FDA's guidance for 95% concordance with the comparator test results, including both the positive and negative percent agreements. we look forward to sharing more detailed data concurrent with our receipt of FDA authorization. In addition to these results, we actively monitor new COVID variants as they arise. Specifically, we continue to conduct in silico analyses to determine the extent to which mutations may impact our test performance and execute in vitro testing of analytic and clinical samples with these specific mutations to confirm no loss of pathogen detection. As a participant in the RADx program, we had the opportunity to assess the impact of 10 distinct COVID-19 variants for our TALIS I test. We were pleased to observe that TALIS I performed very well, demonstrating high sensitivity of detection. At the time of testing in June, the emerging Delta variant was not available to be included in the study. Subsequently, a small internal study showed correct identification of the Delta variant in clinical specimens. Of further note for our FDA submission, we did include findings from this RADx assessment in our EUA submission with the goal of having variant detection reflected in the TALIS I package insert. We believe it is important to share this type of data and welcome the opportunity to benefit public health in this way. turning to our efforts to prepare for commercialization. We are scaling production of our COVID-19 assay to meet demand and prioritizing a thoughtfully planned phase strategy to drive adoption and long-term success. While we are very enthusiastic about our EUA submission, we cannot predict the FDA's timing for authorization, and we still need to finalize validation of our automation lines. Furthermore, variability in COVID testing demand makes it difficult to project the precise ramp of our commercial launch. To advance this next phase of operational growth for TALIS, we have recently promoted Doug Lue to Chief Operating Officer. Doug's strong leadership and experience in these areas, including roles at both QIAGEN and Bayer, will be instrumental in our efforts to continue to establish our manufacturing and R&D programs. Doug will be speaking with you directly later on this call to share further insights into the extensive preparations underway for our manufacturing readiness. On the commercial front, we strive to anticipate customer needs, create exceptional user experiences, and ensure that our TALIS I solution successfully meets the needs of providers and patients alike. To that end, we will execute a controlled launch, beginning with target customers to evaluate TALIS I, followed by a broader market launch. To support these objectives, we continue to build an experienced commercial organization led by our Chief Commercial Officer, Rob Kelly. With more than two decades of sales and marketing leadership experience in the diagnostics industry, including posts at Illumina and Genelight, Rob has established what I believe to be a world-class commercial organization for TALIS, including a global marketing team to create awareness and demand, an enterprise sales team to drive adoption in a variety of healthcare and congregate settings such as schools and the workplace, and a direct sales team to call on urgent care centers, smaller hospitals, and physician practices. Finally, we are building our customer service and commercial operations to anticipate user needs and create an exceptional experience that leads to long-term, loyal use of TALIS I tests. I am extremely proud of the talent we recruited for these roles and am confident that we have the team in place to drive an effective commercial launch and sustained growth. Transitioning to R&D in our pipeline. Our objective remains to broaden our test menu to meet the needs of customers and expand our addressable markets. We had planned to file for EUA submission of our COVID flu and respiratory panel and initiate CTNG trials later this year. In the near term, our development timelines have been extended by delays in the launching of our COVID-19 tests and manufacturing scale. To build capacity to work on multiple programs concurrently, aggressive investment in R&D leadership and personnel remains a top priority for the company. Doug will provide additional detail on our development progress to date and next steps momentarily. Our work in the past quarter has increased our enthusiasm and confidence in the accuracy and broad applicability of the TALIS I system as we continue to build the foundation to advance our pipeline. I will now turn the call over to Doug, who will walk you through an update on our manufacturing and development. Following that, Roger will provide second quarter financials and details on our outlook. Doug?