Opgen Inc

Welcome to the OpGen fourth quarter and full year 2021 earnings call and business update. Today, OpGen management will provide an update on the company's current business and outlook for the future. At this time, all participants are in a listen-only mode. Following OpGen's prepared remarks, there will be a Q&A session. As a reminder, this conference call is being recorded today, March 29, 2022. At this time, we would like to turn the call over to Joe Green, OpGen's IR representative, to provide the opening remarks.

Thank you, Operator, and good afternoon. Before we begin, some important information. Any comments made by management during this conference call may contain forward-looking statements regarding the operations of and future results of OpGen, including its subsidiaries Curatus and Aries Genetics. I encourage you to review opt-in filings with the Securities and Exchange Commission, including, without limitation, the company's most recent Form 10-K for fiscal year 2021 that will be filed with the SEC, which will identify the 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 not limited to, our ability to continue to successfully achieve the expected synergies from the company's completed business combination with Puratus, and to implement our commercial strategy, the impact of the continuing global COVID-19 pandemic on our business and operations, our use of proceeds from recent financings, 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 coven 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 success of our commercialization efforts and partnering strategy, 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, March 29th, 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, Optum's President and CEO, and Albo Weber, its CFO. Now I turn the call over to Oliver for introductory remarks and his report.

Thank you, Joe, and thank you, everyone, for joining us this afternoon. Glad to be sitting here with our CFO, Albert, and reporting on our progress. 2021 was a year filled with progress, and we look forward to highlighting our milestones and achievements throughout this call. As you know, Optin, along with its subsidiaries, is committed to improving patient care and fighting antimicrobial resistance, or AMR, through cutting-edge molecular microbiology. We're developing and commercializing molecular solutions and diagnostic tests to help guide clinician treatment decisions and improve patient outcomes with more rapid and actionable information about life-threatening infections. We've made great progress with our diversified portfolio of products and strategic partnerships, which contribute to our positive outlook for 2022. Today, I'll begin with recent updates on our product and R&D pipeline. Albert will then review Q4 and full-year 2021 financial highlights. Last, I'll preview options' upcoming milestones and catalysts. We'll also make sure to leave some time for a Q&A session. We started off the fourth quarter with multiple achievements and updates, which I will discuss in detail. Within the first few days of Q4, we announced the 510K clearance by the FDA to market our comprehensive molecular diagnostic product, the ACUITIS AMR gene panel. The ACUITIS AMR gene panel accurately detects 28 genetic antimicrobial resistance marker in isolated bacterial colonies from 26 different pathogens. The panel provides clinicians with a way to rapidly and simultaneously test for and identify whether an organism is resistant or vulnerable to selected drugs in nine classes of antibiotics. Options AMR panel can detect antibiotic resistance markers in about two and a half hours compared to one to four days required with classic phenotypic methods. We believe our Acutis AMR gene panel is the first FDA-cleared molecular diagnostic test kit to detect such a broad number of AMR markers from bacteria isolated from any patient specimen. We believe that the Acutis AMR gene panel is an essential and indispensable tool to strengthen effective antibiotic stewardship. We see our product as helping to improve infection control and prevention by helping guide doctors to better target antimicrobial therapy, thus improving patient outcomes. We initiated the commercial launch and rollout of the Acutis AMR gene panel in October of 2021. As stated in our Q3 2021 earnings call, we anticipate the sales cycle for a novel molecular diagnostic test like the AMR panel to be in the 6- to 12-month range. As of today, we're actively engaged in numerous conversations about the Acutis AMR gene panel with large academic centers, state reference labs, and other large, well-equipped hospital labs across the country. we have a healthy and growing funnel of several dozen active opportunities that we're working on. And we have recently provided commercial agreements to several potential accounts in the Northeast and Midwest. These proposals, which remain subject to final negotiations, ranging size from smaller scale initial test volumes of about 100 to 200 tests this year at some sites, relating to expected revenue in the couple of tens of thousands of dollars, all the way to high volume opportunities for as many as 1,000 acute as AMR gene panel tests for a full year once implementation has been completed. Such accounts could then turn into annual revenue-generating opportunities in the $100,000 to $150,000 ranges. The second milestone we announced in October was the commercial launch of ARIS Cloud by our Austrian subsidiary, ARIS Genetics. ARIS Cloud is a simple web-based application available under a subscription model that fully automates data processing to accelerate the analysis of sequenced clinical isolates. The software not only processes data, but also provides insights into clinically and epidemiologically relevant data to researchers around the globe. This includes information on pathogen identity, genotype, virulence, plasmids, and AMR. Powered by Amazon Web Services and using our state-of-the-art AI-powered algorithms and machine learning, this R is cloud-based platform. offers researchers the opportunity to interrogate their own next-generation sequencing, or NGS, data against the RSDB, enabling, for instance, the prediction of antibiograms directly from pathogen genome data. Our first RS Cloud software subscription deals have already been signed in 2022. ARIS Genetics is actively working with clinical expert users. It is collaborating with two major U.S. hospitals to conduct independent studies to evaluate the platform for routine clinical use and for outbreak analysis. Further collaboration agreements with clinical and public health partners in several additional countries are currently underway. In November of 2021, RS Genetics granted permanent, unrestricted, and non-exclusive access to a small subset of its proprietary RSDB data asset to an unnamed global corporation and leader in microbiology and infectious disease diagnostics. RSDB is a growing and continuously curated AMR database of genetic AMR markers, as well as data sets from by now more than 78,000 bacterial isolates. The unnamed IVD Corporation paid RS Genetics in excess of $600,000 for the data transfer and data access fee to approximately 1.1% of RSDB's then current total content. Under this agreement, the partner, furthermore, has the option to purchase at the same price per sample that we agreed upon in November of 2021, additional data sets as they may become available in 2022. Such additional samples and data sets could potentially become available to ARIS as part of its involvement in the large prospective multicenter U.S. clinical trial for the Univero UTI, that is the Urinary Tract Infection Panel. This transaction is yet another example of ARIS Genetics' growing commercial traction. It adds to ARIS Genetics' list of global commercialization partnerships, which already include companies such as Sondos, with whom ARIS recently expanded and extended its strategic collaboration until January of 2025, and QIAGEN, to name a few. Rounding out 2021, ARIS Genetics announced the strategic expansion of RSDB proprietary content, After successfully completing the first phase of its collaboration with a leading US CRO and reference lab, ARIS has now entered the second phase of this collaboration. This phase will provide access to up to 1,000 specifically chosen proprietary clinical isolates from key pathogens. ARIS plans to further increase the value of RSDB and expand its content through strategic collaborations with external partners and supporting clinical trials conducted by option. In 2021, And year-to-date in 2022, RSDB content has grown by more than 40%, and we expect this percentage to continuously expand. As mentioned on our previous earnings call, Albert Weber joined Options in January of 2022 as our Chief Financial Officer and Managing Director of Options Subsidiary Curatus GmbH. Albert has more than 30 years of experience in accounting, controlling, and corporate finance, and has hands-on operational experience in the United States, Europe, and China. He's been a great addition to the team. With that introduction, I turn today's update over to Albert. He will review financial results for the fourth quarter and full year 2021 and recent financial developments of our business. Albert?