Opgen Inc

Welcome to the Opgen first quarter 2022 earnings call and business update. Today, Opgen management will provide an update on the company's current business and outlook for the future. Following Opgen's prepared remarks, there will be a live Q&A session. As a reminder, this conference call is being recorded today, May 12, 2022, and all participants are in a listen-only mode. At this time, we will turn the conference over to Alyssa Factor, OpGen's IR representative, to provide the opening statement.

Good afternoon, everyone, and thank you, operator, for the introduction. Before we begin, I would like to note that any comments made by management during this conference call may contain forward-looking statements regarding the operations and future results of OpGen. including its subsidiaries, Curatus and Ares Genetics. I encourage you to review opt-ins filings with the Securities and Exchange Commission, including, without limitation, the company's most recent Form 10-K and Form 10-Q for the first quarter of 2022 that will be filed with the SEC, which will identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statement. Factors that may affect the company's results include, but are not limited to, the success of our commercialization efforts and partnering strategy, our ability to successfully, timely, and cost-effectively develop, seek, and obtain regulatory clearance for, and commercialize our products and service offerings, our ability to continue to successfully achieve the expected synergies from the company's completed business combination with Curatus, and to implement our commercial strategy, the impact of the continuing global COVID-19 pandemic on our business and operations, and on capital markets and general economic conditions. Our use of proceeds from recent financial filings, as well as our ability to access additional financing in the future. Our ability to satisfy our debt obligations under our loan with the European Investment Bank. The rate of adoption of our products and services by hospitals and other healthcare providers in general, as well as during the current COVID-19 pandemic and geopolitical situation in particular. The effect of the military action in Russia and Ukraine on our distributors, collaborators, and service providers. The effects on our business of existing and new regulatory requirements. and other economic and competitive factors. The content for this conference call contains time-sensitive information that is accurate only as of the date of this live call, May 12, 2022. The company undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call, except as required by law. Joining the call today are Oliver Schach,

options president and ceo and albert weaver its cfo now i will turn the call over to oliver schacht for introductory remarks thank you alyssa and thank you everyone for joining us this afternoon glad to be sitting here in rockville at options global headquarters with our cfo albert and reporting on our progress this was a solid quarter for our products and overall business we've continued to progress in our commercialization and expand and create new partnerships we look forward to to sharing our milestones and achievements throughout this call to highlight our continued growth. Today, I'll begin with recent updates on our product and R&D pipeline. Albert will then review Q1 2022 financial highlights. Last, I'll preview options ongoing and upcoming milestones and business development. We'll also make sure to leave some time for a Q&A session. With that being said, we have a strong start to 2022, and I will begin by discussing our first quarter milestones in detail. As discussed on our last earnings called the Univero A30RQ instruments successfully completed their lifetime testing and met or exceeded all their verification and validation or V&V testing requirements in February. This is a major milestone as it enables us to finalize the new platform instrument and get a first set of series-ready instruments built later this year. Additionally, we're progressing forward on our first A30 cartridge application, a panel for invasive joint infections, or IJI, from synovial fluids. and plan to bring the A30 platform and IGI test into its first clinical trial in the United States later in the fourth quarter of 2022. As we continue to develop the A30 for clinical trials and subsequent FDA submission and clearance and commercialization, we'll be well-positioned to continue partnering and licensing conversations. We're in constant communication and are currently continuing with our strategic, technical, and commercial discussions with multiple parties within the United States, Europe, and Asia. The Hopkins Acutis AMR gene panel was featured in the Journal of Clinical Microbiology in February. This peer-reviewed journal publication clearly demonstrates that the FDA-cleared Acutis AMR gene panel is an accurate method to detect and differentiate a broad range of 28 AMR markers that can be associated with up to nine antimicrobial classes in just two and a half hours. The authors note that, quote, associating the AMR markers with not susceptible phenotypic results is a key differentiator of the FDA- cleared ACUADIS AMR gene panel compared to other molecular panels that simply detect the presence or absence of a gene, end quote. The advantages of ACUADIS AMR gene panel over other currently available molecular tests are, first, AMR detection and linkage to a specific organism, second, a turnaround time of two and a half hours, as I just mentioned, and third, offering what we think is the most comprehensive AMR panel, including non-beta-lactam AMR genes, and that, for might be considered salvage therapy antibiotics, such as colistin, as well as the ability to determine mechanisms of resistance to guide antibiotic selection. For example, whether third-generation cephalosporin is mediated by ESBL or MC, which cannot be assessed with phenotypic AST methods. Overall, we believe that the detection of AMR can help with infection prevention and support hospital antibiotic stewardship and infection control. I'll now turn the call over to Albert Weber, Options Chief financial officer. He will review financial results for the first quarter of 2022 and recent financial developments. Albert.