Opgen Inc

Welcome to the Optin third quarter 2022 earnings call and business update. Today, Optin management will provide an update on the company's current business and outlook for the future. Following Optin's prepared remarks, there will be a live Q&A session. As a reminder, this conference call is being recorded today, November 10th, 2022, and all participants are in a listen-only mode. At this time, we will turn the call over to Alyssa Factor, Optin'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 RS Genetics. I encourage you to review OpGen's filings with the Securities and Exchange Commission, including, without limitation, the company's most recent Form 10-K and Form 10-Q for the third 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 statements. Factors that may affect the company's results include, but are not limited to, the success of the company's commercialization efforts and partnering strategy, its ability to successfully, timely, and cost-effectively develop, seek, and obtain regulatory clearance for and commercialize its products and service offerings, the company's ability to continue to successfully achieve the expected synergies from the company's completed business combination with Curatus and to implement its commercial strategy, the impact of the continuing global COVID-19 pandemic on the company's business and operations, and on capital markets and general economic conditions, the company's use of proceeds from recent financings, as well as its ability to access additional financing in the future, the company's ability to satisfy its debt obligations under its loan with the European Investment Bank, the rate of adoption of its products and services by hospitals and other healthcare providers in general, as well as during the COVID-19 pandemic and geopolitical situation in particular, the effect of the military action in Russia and Ukraine on its distributors, collaborators, and service providers, the effects of the company's 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 of the date of this call, November 10, 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 Schacht, OpGen's President and CEO, and Albert Weber, its CFO. Now we will turn the call over to Oliver for introductory remarks.

Thank you, Alyssa, and thank you, everyone, for joining us this afternoon. On today's call, I will begin with a recap of previous highlights discussed on the second quarter earnings call, followed by recent updates on our products and R&D pipeline. Albert will review the financial highlights from the third quarter and offer an update to our guidance. I will then provide an outlook on options ongoing and upcoming milestones and business development, followed by a Q&A session. At the beginning of this quarter, options subsidiary, Aris Genetics, signed a research collaboration agreement with the Belgian National Reference Center for Invasive Streptococcus Pneumoniae at the University Hospital, Leuven. The US Center for Disease Control, CDC, has classified drug-resistant streptococcus pneumoniae as a serious antimicrobial resistance, or AMR, threat. And AMR is one of the top 10 global public threats. This presents an unmet need for effective diagnostics. Under the agreement, the partners aim to employ machine learning tools for antibiotic susceptibility testing. In August, we launched the RS-ISS isolate sequencing services from our Rockville, Maryland lab at Optum. We're now able to serve U.S. customers directly in the U.S., providing easy access to our RS technologies from Optum's commercial lab. By expanding our services and offerings in the United States, we're continuing on the path to generating revenue-producing opportunities. Our U.S. lab facilities will also enable an expedited turnaround on the next-generation sequencing, or NGS, work related to the Univero Urinary Tract Infection, or UTI, clinical trial. In October, we announced completion of enrollment of our major prospective multicenter clinical trial in the U.S. on the Univero 850 platform for the Univero UTI panel. We enrolled over 1,800 patient samples and exceeded our goal of 1,500 prospective samples. We expect to conclude reference testing in the next few weeks and anticipate the unblinding of data in December this year, which we will discuss in more detail later in this call. Following the Univero 850 UTI product, we'll be looking to develop our first products on the Univero 830 platform. These will include bringing into clinical trials an invasive joint infection, or IJI panel, as well as working on a panel focused on AMR markers from blood cultures for low- and middle-income countries, or LMICs, under our FIND collaboration, which began in September. The initial feasibility phase of the collaboration with FIND is expected to be completed at the end of March 2023 and is forecast to deliver six proof-of-concept deliverables, such as panel definition for an AMR-focused cartridge, certain assay development work, prototype definition, and development towards an A30 touchscreen cockpit. The FIND program will focus on detecting pathogens and AMR markers from common blood culture bottles. The €700,000 in co-funding by FIND and German KfW Bank will also allow us to develop prototypes of a dedicated A30 touchscreen cockpit that will be suitable for use in LMIC settings. Optin signed its second commercial customer contract for the Acutis AMR gene panel in the third quarter. Additionally, we have several ongoing contract negotiations in the final stages undergoing legal and commercial review. We recently announced a collaboration agreement between Bioversus AG from Switzerland and Curatus for the development and use of the Univero platform in Bioversus' upcoming phase two clinical trial of novel drug candidate BV100. BV100 is used to treat serious infections in patients with mortality rate of around 50% with little to no effective and safe treatment options. In the phase two clinical trial, all hospital sites will be using our Univero hospitalized pneumonia or HPN cartridge as a rapid diagnostic test to help optimize enrollment. We estimate that the first trial sites will start coming online early next year and estimate at least 18 months for a trial at somewhere around 10 to 20 trial sites across different European countries. We anticipate revenues of a couple hundred thousand dollars over the duration of the trial for Univero systems that will be rented, cartridges sold, support as well as training delivered to Bioversus and their clinical research organization. This week, Optin's board elected Yvonne Schleppi as a new independent non-executive member of the company's board of directors. Ms. Schleppi brings legal governance, life sciences, and international experience to the board. Since 2011, Ms. Schleppi has served as a managing partner of Strativise LLC, an international strategic advisory firm that she co-founded. Prior to founding Strativise, Ms. Schleppi served as general counsel at Global Enterprise Technologies, passport and ID, a high-security document printing solutions provider, and systems integrator from 2007 to 2011. and as Executive Vice President, General Counsel, and Corporate IP Officer at Organon Biosciences, a global pharmaceutical, animal health, and biotech group based in the Netherlands, from 2006 until its sale in 2007. Prior to that, Ms. Schleppi was a partner at the Boston-based law firm of Palmer & Dodge LLP, where she served as chairperson of that firm's international practice group. Ms. Schleppi has been recognized by the National Association of Corporate Directors as directorship certified, has served on the board of directors of several public companies, and currently is a member of the board of Astronova Inc. I will now turn the call over to Albert Weber, Options Chief Financial Officer. He will review financial results for the third quarter and recent financial developments. Albert.