Talis Biomedical Corporation

Good day, ladies and gentlemen, and welcome to the TALIS Biomedical 3rd Quarter 2021 Earnings Conference Call. At this time, all participants are in the listen-only mode. Later, we will conduct a question-and-answer session, and instructions will 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 your host, Emily Fawcett. SVP Corporate Communications and Investor Relations. Thank you. Please go ahead.

Good afternoon, and thank you for participating in TALIS' third quarter conference call. Joining me today are Kim Popovitz, our Interim Chief Executive Officer, Roger Moody, our Chief Financial Officer, Doug Liu, our Chief Operating Officer, and Rob Kelly, our Chief Commercial Officer. Earlier today, the company released its financial results and business progress for the quarter ended September 30th, 2021. A copy of that press release can be accessed on the investors page of our website at talusbio.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 the federal securities laws. These statements involve material risk 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 TALIS issued today. For a more complete list and description, please see the company's filings with the SEC, including the risk factor section of the company's 10-Q filed with the SEC on November 15, 2021, and in its other filings. 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, November 15, 2021. With that, I would like to turn the call over to Kim.

Thanks, Emily. Good afternoon, everyone, and thank you for joining us. It's been both an honor and pleasure to work with the TALIS team these past few months. Our work together has further strengthened my conviction in the importance of the TALIS mission to address the significant and growing demand for access to fast and accurate diagnostic results in the moment of need. With the recent announcement of our emergency use authorization for the TALIS I COVID-19 test system, We have achieved an important business milestone towards the advancement of health equity and outcomes by delivering accurate infectious disease testing at the point of care. In addition to the very welcome news of the EUA, I'm also delighted to share that Brian Blazer will be joining TALIS as President, Chief Executive Officer, and Director, effective December 1st. Brian has more than 25 years of senior leadership experience in the in vitro diagnostics industry, including 17 years at Abbott, where he oversaw the company's global diagnostics organization, including its core laboratory, point of care, rapid diagnostics, and molecular diagnostics businesses. His experience and track record in leading transformational strategies to launch innovative diagnostic products, drive commercial growth, and scale global operations is ideal for the magnitude of our opportunity ahead. We are confident that Brian is the right person to lead TALIS through our next phase of growth in achieving our bold mission and business objective. Turning now to an update on our business performance, we are pleased to report meaningful progress against our previously outlined initiatives, most notably the FDA's granting of the EUA for use of our TALIS I COVID-19 test system in a variety of healthcare settings. This important achievement reflects our team's deep commitment to develop a sample-to-answer diagnostic solution that enables users to offer patients the accuracy of central laboratory-run results without the wait. In a clinical study of samples collected and tested in point-of-care settings, the TALIS-1 COVID-19 test system demonstrated 100% concordance with comparator test results, including both the positive and negative percent agreements. The TALIS-1 COVID-19 test system targets two genes, ORF1AB and N, to ensure sensitivity and the inclusion of variants. As a participant in the RADx program, we assessed the impact of 10 distinct COVID-19 variants demonstrating high sensitivity of detection. At the time of this testing in June, the emerging Delta variant was not available for inclusion in the study. Subsequently, we conducted a separate bioinformatic analysis for the Delta variant as well as testing of in vitro transcript samples to further support our EUA submission. In testing for all these variants, including Delta, no loss in sensitivity or impact on the TALIS I COVID-19 test system's performance was detected. Importantly, we continue to monitor new COVID variants as they arise in accordance with FDA guidance. With the EUA in hand, we have turned our attention toward the steps required to execute a controlled product rollout of the TALIS I system. a platform that is intended to serve customers across multiple infectious diseases over time. We are pleased that with the COVID assay, our customers can gain experience with the instrument as we move to clinical testing. Our approach will be measured to ensure we deliver an experience that will drive long-term system adoption. With this in mind, I will turn the call over to Rod Kelly, our Chief Commercial Officer, to provide an update on commercial readiness. Following that, Doug Liu, our Chief Operating Officer, will address our manufacturing progress next steps towards meeting commercial demand and our pipeline opportunities. Roger Moody, our chief financial officer, will then provide an update on third quarter financials before turning the call back to me for closing remarks. Rob?