Opgen Inc

Good morning, and thank you for joining us today. I would now like to hand the call over to Megan Paul of Investor Relations. Megan, the floor is yours.

Welcome to the OpGen first quarter 2021 earnings call and business update. At this time, all participants are in a listen-only mode. Following management's prepared remarks, there will be a Q&A session. As a reminder, this conference call is being recorded today, May 13, 2021. Before we begin, I would like to caution you that comments made during this conference call by management may contain forward-looking statements regarding the operations of and future results of OpGen, including its subsidiaries, Curitas and Ares Genetics. I encourage you to review OpGen's filings of 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 2021 that may be filed with the SEC, 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, our ability to successfully achieve the expected synergies from the company's completed business combination with Curitas, and to implement the combined company strategy, the impact of the continuing global COVID-19 pandemic on our business and operations. our use of proceeds from the at-the-market offering that we commenced in February 2020, as well as the proceeds from recent warrant exercises and financing, such as the November 2020 pipe and February 2021 registered direct, pursuit of FDA clearance for the Acutus AMR gene panel for use of bacterial isolate, and for other products and services. The rate of adoption of our products and services by hospitals and other healthcare providers in general as well as in the current COVID-19 pandemic situation in particular. The success of our commercialization efforts and partnering strategy, the effects on our business and existing of 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 13, 2020-21. 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 will be Oliver Schacht, President and CEO, and Tim Deck, CFO of OpGen. I would now like to turn the call over to Oliver Schacht for introductory remarks.

Thank you, Operator, and thank you, everyone, for joining us this morning. We're very pleased with our first quarter performance and are undoubtedly off to a strong start to 2021. We have an exciting, diversified portfolio of products in a strong cash position that supports an attractive combination of product revenue and partnership growth. We anticipate a robust pipeline of activity in the months ahead and look forward to establishing ourselves as industry leaders in the molecular diagnostics and bioinformatics space and believe we're well on the way. On today's call, we'll begin by discussing recent business highlights, as they relate to the company's core capabilities and top-line growth prospects. I will then pass the call over to Tim to review financial highlights from the first quarter, as well as recent financing activities. We'll then wrap up the call with an update on the company's strategic initiatives and pipeline outlook. I wanted to start by providing an update on one of the product portfolios Optin has previously highlighted with an improved focus for the company. our proprietary univiral platform and unique bioinformatics capabilities. This focuses on expanding the platform to include complicated urinary tract infections and invasive joint infections in the United States, with two upcoming prospective multicenter clinical trials for future FDA submission. Both clinical trials are anticipated to start in the second half of 2021, with the UTI trial in the summer and the IJI trial late in the year. We had submitted materials for a potential pre-submission meeting with the FDA for the Univero UTI product in the first quarter of 2021. Not too surprising, the FDA at this time has declined to host pre-submission meetings due to the ongoing pandemic. An option will be proceeding without such a voluntary meeting as FDA had indicated that they would require a resubmission of such a request and then would take many months before being able to review materials in preparation of such a meeting opportunity. Given that similar products in both clinical indications using identical corresponding sample types have been successfully developed on the Univero platform and CE-IVD marked and are commercially available in Europe and other markets today, Optin does not consider the FDA's inability to conduct such a precept meeting to be a material disadvantage at this time. Most excitingly, as it relates to our Univero platform, We announced earlier this year that we received regulatory approval from the Chinese NMPA for the Curatus Univero system as an IBD instrument system. Options subsidiary Curatus and its Chinese partner, Beijing Clear Biotech, continue to closely interact with the NMPA as it continues its review of the Univero A50 pneumonia cartridge. The product is the first Univero-based diagnostic application for the Chinese market. A dossier for the review and potential future approval of the pneumonia cartridge was also provided. This dossier includes comprehensive data from various clinical trials and regulatory submissions of the Univero LRT and LRT-BAL products, both of which are FDA-cleared here in the U.S., and the Univero HPN cartridge for hospitalized pneumonia patients, which is CE-IBD marked in Europe. The start of commercialization by our partner, BCB, remains subject to approval of the pneumonia cartridge, which is still pending. We hope to be able to provide updates on the Chinese regulatory approval process and subsequently plan commercial launch in the coming quarters in 2021. At this point in time, however, the NMPA does not provide any specific guidance or timelines for their reviews. As mentioned before, The commercial side of the contract with Beijing ClearBio has been negotiated, and the deal was signed several years ago. To reemphasize, there is no need to negotiate a commercial deal in China anymore. It's already in place, and it contains minimum commitments of 360 Univero systems and 1.5 million cartridges over an eight-year period, cumulatively adding to about $180 million in revenue to option at current transfer prices in the agreement and at current Eurodollar exchange rates. On the topic of partnerships, in January, we announced that options subsidiary Curatus had entered into a distribution partnership with Anar Health Technologies in Colombia. Anar, headquartered in Bogota, is Colombia's leading diagnostics distributor and is already working with numerous renowned global IVD manufacturers. Under the distribution agreement, Anar has the exclusive rights to commercialize the Curatus Univero A50 instrument system, and its full suite of Univero infectious disease diagnostic application cartridges in Colombia. The distribution agreement has an initial term of three years, and it can be extended in one-year increments. In return, ANAR has committed to significant minimum purchases of Univero instruments and application cartridges over the initial three-year term, amounting to a total of at least 10 Univero systems plus significant numbers of Univero cartridges. ANAR is responsible for product registration, which has progressed nicely for the Univero platform and the entire portfolio of Univero cartridges during the first quarter and year-to-date in 2021. And they're actually working on an accelerated preliminary registration for the Univero system. ANAR is committed to introduce the Univero product line to the Colombian market. We continue to be encouraged by this partnership as it strengthens our commercial presence in Latin America and and is in alignment with our core commercialization and revenue growth strategy. In early 2021, as part of the launch preparation, a highly successful pre-marketing event was held at the 12th International Symposium on Bacterial Resistance, Diagnostic Stewardship, and Infection Control from February 24th to 26th, 2021, in Colombia. Option session within this program, where one of our key opinion leaders presented, was titled Detecting Antimicrobial Resistance Genes to Guide Patient Care. on February 25th. In March, we announced the final data from the Karolinska Institute study following publication in a peer-reviewed journal. This paper highlights options univaro HPN products for hospitalized patients with pneumonia, demonstrating a higher diagnostic yield than bacterial culture, with a high negative predictive value of 99.8% for pathogen detection. This strong performance data comprehensive coverage, and turnaround time of less than five hours from sample to result provides clinicians earlier data to inform antimicrobial decisions, especially in critically ill COVID-19 patients. As it relates to the Univero product line, I wanted to highlight the outcome of our very successful and highly attended webinar titled Pneumonia Diagnosis, Bacterial Superinfection in COVID-19 Patients that took place in April. Professors Christian Gieske, at the Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden, and Drew Bell, the Medical and Public Health Microbiology Fellow at Indiana University School of Medicine, Indianapolis, presented their independent study results from the univaro-hospitalized pneumonia, HPM, and univaro-lower respiratory LRTBAL panels. Their studies demonstrated that syndromic testing of lower respiratory specimens with univaro-HPM and LRTBAL panels can indeed improve patient care, and time to appropriate targeted antibiotic therapy in COVID-19 pneumonia patients, as well as in non-COVID-19 population with a suspicion of pneumonia. The webinar highlighted that Univero detected bacterial pathogens up to seven days earlier and would have enabled prompted appropriate targeted antibiotics in 41.3% of cases and reduced time to appropriate therapy by 25.7 hours. Now, Shifting gears, I would like to discuss options subsidiary Ars Genetics activity contributing to top-line growth this quarter. We were excited to announce that Ars Genetics and Sondos, the number one global supplier of generic antibiotics, not only extended their collaboration within its pharma partnering program, but Sondos also added and procured another joint project in the first quarter of 2021 to assess the potential of molecular surveillance for better informed therapeutic guidance and antibiotic stewardship. The overall goal of this partnership is to develop a digital anti-infectus platform combining established microbiology laboratory methods with advanced bioinformatics and artificial intelligence methods to support drug development and lifecycle management. As it relates to Irish genetics, in February, we announced a peer-reviewed study highlighting best practice techniques for accurate antimicrobial resistance prediction. This study focused on whole genome sequencing data that supports harmonization of the development of good machine learning practices. This study adds to Ars Genetics' publication record, further validating our approach to becoming a globally recognized leader in the development of AI-powered, next-generation sequencing solutions for infectious disease testing. Addressing the U.S. FDA Action Plan, by developing good machine learning practice and robust algorithms will be key to moving our AI-powered solutions into clinical practice. Applying the proposed best practice techniques to RSTB allowed us to further improve predictive performance of whole genome sequencing-based AST. In this context, We're currently also working with several leading clinical centers in the United States to further demonstrate the potential of accurate whole genome sequencing-based AST and independent validation studies. We also received great news this quarter relating to our work with the New York State Department of Health. Opgen announced that our collaboration using a state-of-the-art solution to detect, track, and manage antimicrobial-resistant infections statewide has expanded and extended beyond the second-year expansion phase by another six months through September 30th of 2021. The six-month extension and expansion contract is valued up to an additional $540,000, which includes a quarterly retainer-based project fee as well as volume-dependent per-test fees. We're providing our ACUIDIS AMR gene panel for isolates for rapid detection of multidrug-resistant bacterial pathogens along with our Acutis Lighthouse software for high-resolution pathogen tracking. We anticipate that with our innovative solutions, we'll be able to proactively identify such pathogens, leading to early intervention and potentially life-saving treatment. This six-month extension period gives us time to also discuss and evaluate potential future forms of collaboration with the New York State Department of Health across the state. As of today, four testing centers that run the ACUTUS AMR gene panel tests on isolates are up and running, servicing more than 30 affiliated hospitals. We've seen significant ramp-up in testing volumes in the first quarter and into the second quarter of 2021. I will now turn the call over to our Chief Financial Officer, Tim Deck, who will review financial results for the first quarter and discuss recent financial developments for the business. Tim?