Talis Biomedical Corporation

Good day, and thank you for standing by. Welcome to the TALIS Biomedical Second Quarter Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and an answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Ms. Emily Fawcett. Please go ahead.

Good afternoon and thank you. Joining me today are Rob Kelly, our Chief Executive Officer, and Becky Markovich, our Interim Chief Financial Officer. Earlier today, the company released a business update and financial results for the quarter ended June 30, 2023. A copy of that press release can be accessed on the investor page of our website at talusbio.com. Before we get started, I would like to remind you that management will make remarks during this call that are forward-looking statements within the meaning of the 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 a section entitled forward-looking statements in the press release that TALIS Bio issued today. For a more complete list and description, please see the company's filings with the SEC, including the risk factors section of the company's annual report on Form 10-K, filed on March 22nd, 2023, as may be supplemented from time to time in its other filings. Except it's required by law, TALISbio 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 on August 10, 2023. With that, I would like to turn the call over to Rob.

Thanks, Emily. Good afternoon, everyone, and thank you for joining us on today's call. Before we begin, I would like to take this opportunity to welcome two distinguished leaders to Thales Bio. In May, we appointed Dr. Heiner Dreisman to our board of directors. Heiner's entrepreneurial vision and track record leading multiple corporate functions over the course of his 20-year tenure at Roche, including as president and chief executive officer at Roche Molecular Systems, make him a great fit for the large opportunities ahead of us. Last week, Dr. Andrew Lukowiak joined our executive team in the newly created role of President and Chief Scientific Officer. With more than 20 years of senior leadership experience in the clinical diagnostics industry, Andrew will be responsible for R&D, clinical and regulatory, manufacturing, and operations. During this pivotal period of execution at Thales Bio, Andrew's executive experience and proven ability to bring products to market, from concept to commercialization, will fortify the strong teams we have built to deliver the TALIS I test menu. We look forward to benefiting from both Heiner and Andrew's seasoned perspective as we advance our mission to deliver accurate infectious disease testing in the moment of need at the point of care. Turning now to our recent business progress to support the strategic imperatives that we laid out in May. As a reminder, we are prioritizing the development of four infectious disease test panels that women's and sexual health providers want to offer at the point of care based on our market research. Our initial plan test menu consists of a respiratory panel for influenza A, influenza B, and COVID-19, or fluvid, chlamydia, gyneorrhea, Entrichomonas vaginalis, or CT-NGTV, herpes simplex virus, or HSV 1 and 2, and a vaginal infection panel. In order to bring these test panels to market as soon as possible, we are leveraging progress made to date with our COVID-19 test to support 510 clearance of the TALIS I system while we complete development of our broader test menu. We are executing a disciplined regulatory strategy designed to minimize risk and accelerate time to commercialization and have made important progress towards our goal of securing clearance for three test panels before the end of 2025. Specifically, our COVID-19 clinical study to support 510 clearance for the TALIS I system is underway. And we are preparing to initiate a clinical study for a fluid panel. As a reminder, we know from our market research that OBGYNs are interested in respiratory testing for pregnant patients and women in the course of their care. As such, we plan to pursue 510 clearance of our Fluvid Panel to create initial demand and experience with our platform while we complete development of our broader TALIS I test menu. We are also beginning to work on our FDA pre-submission for HSV and to select sites for our CTNG-TV clinical study that will enroll up to 5,000 patients collectively across OBGYN offices, STI clinics, and urgent care centers. Turning now to clinical development, new data presented at IDSOG, the Infectious Disease Society for OBGYNs, annual meeting last month, gives us confidence that we are on the path to developing a viable and differentiated test menu. First, a feasibility study of our development stage CT, NG, and TV assays demonstrated, in less than 30 minutes, clinical performance comparable to widely used on-market molecular tests. This preliminary clinical performance was assessed using residual clinical samples initially tested by central lab platforms that require up to 90 minutes to generate a result. In neat male urine, positive results matched 100% for CT NG, and TV against the comparators, while negative result agreement matched 100% for CT and NG and 98% for TV. In vaginal swabs, where only positive samples were tested, results matched 100% for CT and NG and 90% for TV against the comparators. In a separate previous study where negative vaginal swabs were tested against the CT-NG comparator, results matched 100%. We are encouraged that a CT-NG-TV multiplex test is feasible on a molecular point-of-care system and believe access to test results during a single patient visit will enable providers to make informed treatment decisions and become better stewards of antibiotic use. A second study also presented at IDSOG demonstrated our ability to effectively lyse challenging fungal pathogens in under four minutes on the TALIS-1 system. This achievement is a critical step in developing our point of care vaginal infection panel. Our scientists performed initial experiments to determine lysis efficiency with and without bead beating used on the system's on-cartridge mechanical lysis chamber. These studies demonstrate that mechanical lysis using bead beating on the TALIS-1 system led to effective lysis of multiple Candida species. releasing sufficient target nucleic acids for detection at concentration levels comparable to limits of detection of three on-market vulvovaginal candidiasis IVD tests. Based on these positive early results, the TALIS-1 system may be able to achieve these limits of detection while having a turnaround time that is approximately 30 to 90 minutes faster than these comparator tests. We believe the ability to lyse difficult pathogens and to purify and concentrate nucleic acids to deliver lab quality test results in less than 30 minutes will be a key differentiator from current platforms. Moving to manufacturing, where we have established capabilities with the flexibility and stability to address all stages of our business. Our semi-automated cartridge manufacturing line in Chicago is now operational to support all of our upcoming verification and validation activities and eventually early commercialization efforts. As a reminder, this line has the capacity to produce 2,000 cartridges per day. To drive further operational efficiency and spending reduction, we continued to restructure relationships with our contract manufacturing partners. During the second quarter, we transitioned to a new instrument manufacturer and are now in the process of ramping up our new partner while we continue to draw from our internal instrument inventory. As previously disclosed, we have built several hundred instruments to date and have raw materials to build thousands more. Additionally, to streamline our supply chain, we have transitioned away from our raw card manufacturer in Germany to a new partner located here in the United States. We also entered into a new license agreement that allows us the freedom to operate with respect to manufacturing this key component of our cartridge. We believe these changes will further increase our ability to manufacture with speed and quality required to scale when we commercialize. In summary, our team's focused execution is delivering progress across our strategic imperatives. Our COVID-19 study is underway. We are preparing for clinical studies to support our broader test menu. We have generated positive data that positions us to develop differentiated CT-NG and vaginal infection panels and we are continuing to optimize manufacturing processes to support all of our upcoming clinical studies as well as early commercialization efforts. With these accomplishments, we believe we are well positioned to deliver three cleared test panels for the women's and sexual health markets by the end of 2025. Now I will turn the call over to Becky to walk through our second quarter results.