|Over a week ago|
OpGen files to sell 450K shares of common stock for holders 17:1406/1706/17/20
Alliance Global Partners sees OpGen preliminary data as positive » 14:4706/0906/09/20
Alliance Global Partners…
Alliance Global Partners analyst Ben Haynor reiterated a Buy rating and $5 price target on OpGen following the company releasing preliminary data on the performance of the Unyvero HPN panel for pneumonia in detecting life-threatening bacterial co-infections in COVID-19 ICU patients. The analyst said that, while the data is preliminary, he see the results as "positive" for OpGen. Haynor believes OpGen shares are attractive given its multiple catalysts and the potential to benefit from the COVID-19 pandemic, but he cautioned that the company will need to raise additional capital.
OpGen releases preliminary data on Unyvero HPN panel for pneumonia » 07:3206/0906/09/20
OpGen announced preliminary data from an investigator initiated collaboration with Karolinska Institutet, Stockholm, Sweden, to identify bacterial co-infections in hospitalized patients with COVID-19 pneumonia. The patients in this cohort had been admitted to the ICU after respiratory deterioration during hospital stay, and their lower respiratory tract samples were analyzed with the Unyvero HPN panel. Preliminary data demonstrates that the performance of the Unyvero HPN Panel for pneumonia as compared to bacterial culture is strongly concordant for organism targets. In 31 out of 35 patient samples that were evaluated, Unyvero results confirmed all pathogens reported by culture. Unyvero detected additional pathogens in 7 patients, one of which was subsequently tested again by microbiological culture 7 days later and confirmed positive. These results indicate that the Unyvero system, while not always completely concordant with culture results, can detect possible pathogens which are missed by culture. Results obtained by the Unyvero Panel in five hours instead of up to several days by culture methods provides clinicians with an early organism differential, including information on antibiotic resistance markers, allowing earlier treatment decisions and support for antimicrobial stewardship efforts. Among the 35 lower respiratory specimens tested to-date, 63% were tracheal aspirate, 34% BAL/mini-BAL, and 3% sputum. The samples were derived from patients admitted to ICUs in four acute care hospitals in Sweden - Karolinska University Hospital, Solna; Karolinska University Hospital, Huddinge; South General Hospital; Danderyd Hospital, and were taken from a patient population of SARS CoV-2-positive patients being admitted to the ICU. Patients were sampled during their hospital stay for suspected hospital-acquired pneumonia, as they were already in crowded hospitals and had experienced deterioration and inevitably requiring ventilators. Of the above-described patient population, one in four tested positive for a bacterial co-infection by microbiology. High-risk COVID-19 patients, especially in intensive care units and on ventilation, many of whom may be elderly or have preexisting conditions that compromise their immune system, are at a higher risk of acquiring bacterial co-infections that pose severe life-threatening complications. These co-infections are not always easily determined based on clinical symptoms alone, and, if they go unnoticed or diagnosis is delayed, it can lead to dire outcomes including mortality. Within this preliminary study, the median patient age was 58 years old. The Unyvero Hospitalized Pneumonia panel detects 21 clinically relevant pathogens and 19 antibiotic resistance markers in less than five hours directly from native specimen with only around two minutes of hands-on time, compared to routine bacterial cultures that can take up to several days for confirmatory pathogen identification and antimicrobial susceptibility testing results. In the U.S., the Unyvero LRT and LRT BAL panels for rapid detection of lower respiratory tract infections such as pneumonia are FDA-cleared for tracheal aspirate samples and bronchoalveolar lavage fluids, respectively. Unyvero HPN and LRT BAL are the only syndromic pneumonia panels that also include Pneumocystis jirovecii, a key fungal pathogen often found in immunocompromised patients that can be difficult to diagnose.
|Over a month ago|
OpGen, NYS DOH collaboration extension 'highly positive,' says Alliance Global » 11:4106/0306/03/20
Alliance Global Partners…
Alliance Global Partners analyst Ben Haynor reiterated a Buy rating and $5 price target on OpGen (OPGN) after the company said its collaboration with the New York State Department of Health's Wadsworth center to detect, track, and manage antimicrobial-resistant infections has been extended for another year. Haynor views the advancement of the collaboration as a "highly positive" signal for the future of the program as the three main parties, which includes Merck's (MRK) ILUM Health Solutions, have been involved in significant developments or challenges in recent months. The analyst added that he expects the agreement to expand to additional healthcare facilities and to track other pathogens as more funding becomes available.
OpGen expands partnership with NY State Department of Health and IDC » 06:0906/0306/03/20
OpGen's strategic collaboration with the New York State Department of Health to develop a state-of-the-art solution to detect, track, and manage antimicrobial-resistant infections at healthcare institutions statewide is entering into its second year expansion phase. OpGen will continue to work together with DOH's Wadsworth Center, participating healthcare systems, and collaborators such as Infectious Disease Connect, which recently combined with ILundefinedM Health Solutions, to expand the reach of the platform, increase the volume of testing, and enhance data collection. The second-year expansion phase will focus on integrating real-time epidemiologic surveillance with rapid delivery of antibiotic resistance results to care-givers via web-based and mobile platforms. The second year contract includes a quarterly retainer-based project fee as well as volume-dependent per test fees for a total contract value of up to $450K to OpGen.
OpGen chairman says 'excited' about prospects for the company » 07:5705/1105/11/20
OpGen issued two letters…
OpGen issued two letters to stockholders from new OpGen CEO Oliver Schacht and Chairman of the Board William Rhodes. Rhodes said, in part, "In this exciting time for OpGen, I am honored to have been elected as the Chairman of the Board of the Directors of OpGen following the completion of its business combination transaction with Curetis. After five years as Chairman of the Supervisory Board for Curetis and a 14-year career at Becton Dickinson and Company, where I held several senior leadership positions, I am delighted to be chairing this distinguished Board of Directors and anticipate significant, value-creating opportunities for the company. OpGen has been developing industry leading, AI-powered diagnostics and data-driven solutions serving hospitals and patients successfully for many years. This is a particularly dynamic time for our enterprise as we integrate the two businesses and push to further diversify our product portfolio. Our newly constituted Board consists of six members representing expertise from both companies; there are currently four members named by Curetis and two from the pre-combination Board of OpGen. Changes to the Board include Evan Jones, formally OpGen chairman and CEO to join as a non executive director who will help with the transition. Don Elsey will continue as chair of the audit committee joined by Mario Crovetto and Prabha Fernandes, former Supervisory Board directors of Curetis. Thus, the reconstituted Board of Directors consists of myself, Mr. Schacht, Mr. Jones. Mr. Crovetto, Dr. Fernandes, and Don Elsey. These individuals bring a strong understanding of the diagnostic and AMR space as well as significant finance, healthcare, marketing and business development expertise. I look forward to working with such a diverse and talented group of individuals as we lead the company towards value-creating opportunities. Since the beginning, the cornerstone of success of our pre-combination businesses has been the shared vision and mission to develop, manufacture and commercialize proprietary solutions for rapid, molecular diagnostics of severe life-threatening infectious diseases. Following completion of our combination, our fundamental business now offers a much broader, diversified portfolio of products, platforms and bioinformatic solutions. Not only do our business outlooks and industry goals mirror one another, but our combined management and executive teams complement each other as one new combined team. As we embark on integrating our businesses, teams and products over the coming months, the pace and success of our pipeline rollout will largely be determined by the successful execution of our integration strategies. Additionally, a key driver of the Curetis' core business will be OpGen's existing Nasdaq listing and thereby access to U.S. capital markets. This opportunity provides access to a much broader and deeper pool of capital within the U.S. market, ultimately giving the company a larger platform to drive business and pipeline growth. We are excited about the prospects for the company, as we expect to be able to achieve more sustainable growth combined than as separate entities. We anticipate multiple FDA clearance opportunities and we strive to integrate our premier bioinformatics solutions and databases. We will deploy our PCR platforms such as Unyvero and Acuitas as well as our ARESdb and Lighthouse knowledgebase and offer services and strategic partnering opportunities for our next generation sequencing and AI-powered prediction algorithms. Ultimately, the prospect of having the ability to control our own destiny and steer our proprietary platforms is exciting. This offers partnering, commercial and financing opportunities that will likely provide stockholders with attractive entry and exit opportunities. In conclusion, on behalf of the Board, I thank you for your unwavering support of the new OpGen. We remain committed to our mission and to the hospitals and communities that we serve. 2020 will be an exciting year as we continue to build the business and deliver on our commitment to premier AI-powered solutions to the AMR crisis."
OpGen CEO expects top-line revenue to continue to grow in years ahead » 07:5505/1105/11/20
OpGen issued two letters…
OpGen issued two letters to stockholders from new OpGen CEO Oliver Schacht and Chairman of the Board William Rhodes. Schacht's letter read in part, "As the newly appointed president and CEO of OpGen I want to take a moment to formally introduce myself and share the vision our new management team has for the company with regards to our business outlook, product pipeline and growth strategy for this year and beyond. This is an exciting time for OpGen, and I very much look forward to working with the entire team through the next phase of its growth...This business combination is centered on achieving high growth while leveraging operational efficiencies and maintaining financial discipline as we press forward toward our primary vision - to help solve the looming AMR crisis while preserving antibiotics as effective weapons through more advanced, rapid diagnostic testing. Our state-of-the-art robotic manufacturing facility in Germany, as well as our strong U.S. sales and marketing team and dedicated European commercial partner support team, will be key assets in our post-combination success. OpGen, with Ares Genetics, has access to even more advanced bioinformatics capabilities that can be leveraged to integrate the company's AMR databases, data analytics and reporting platforms to innovate next-generation sequencing-based solutions for infectious disease diagnostics in the future. These synergies are undoubtedly drivers of the core business and are expected to increase stockholder value. Our mission at OpGen is to develop, manufacture and commercialize novel solutions for rapid, molecular diagnostics of severe life-threatening infectious diseases in hospitalized patients. Our company offers integrated solutions that cover unique and differentiated diagnostics test panels, powerful AI-driven bioinformatics and software tools that help find and track multidrug-resistant microorganisms. Our ability to do so will depend on us achieving certain milestones in the short, medium, and long term, as I'll outline below. We must first complete the post-combination integration between the OpGen and Curetis and Ares Genetics businesses across all international teams within the U.S., Germany and Austria offices, which we are working on with full speed to complete as soon as possible. From a product standpoint, our near-term business rollout includes the anticipation of combining Ares Genetics and Acuitas Lighthouse databases and bioinformatics capabilities to bring a combined offering to customers, partners and labs globally. A key milestone for the company will be the expected near-term FDA clearance decision for our Acuitas AMR Gene Panel diagnostic test. We are working actively with the FDA to address any last remaining open items from the interactive review process. While we anticipate the review process is nearing completion, we still expect COVID-19 related delays to the second interactive response review and final timing is hard to predict at this point. As we work through that FDA process, we will also evaluate and prioritize across the entire OpGen group portfolio of R&D programs, platforms, and product development opportunities to select those that we believe have biggest impact and stockholder value creation potential in the near term as well as longer term growth potential. As we look beyond this year, we will seek to consolidate the existing OpGen and Curetis diagnostic test menu on fewer platforms and anticipate bringing the Unyvero A30 RQ platform to market with strategic partners. The rollout and launch of the Unyvero platform and pneumonia test pending China NMPA approval will be a key milestone for the company. Additionally, we hope to bring the combined OpGen portfolio of products to global markets in Europe, Asia Pacific and other global markets through our strong distribution network that we expect to continue to expand further over time. We will also seek to raise additional capital for OpGen. We will consider all instruments at our disposal in terms of equity, debt, non-dilutive grant funding as well as partnering and licensing models as a source of further non-dilutive funding with the consistent goal of optimizing stockholder value. In closing, I am confident that we will be able to establish OpGen as an industry leader in the fight against AMR. We anticipate this business combination will maximize value for our stockholders through a broad and exciting product portfolio with proprietary assets for developing and commercializing innovative, data-driven solutions in infectious disease diagnostics. We anticipate for these reasons our top-line revenue will continue to grow in the years ahead as we use operational efficiencies and synergies to reduce cash burn. Together, with your continued support, we aim to create sustainable stockholder value and expand our proprietary product portfolio capabilities through seeking opportunities that present significant growth potential for the company."
Curetis, Karolinska Institutet collaborate to study bacterial co-infections » 09:1804/2104/21/20
OpGen announced the start…
OpGen announced the start of an investigator initiated collaboration with Karolinska Institutet, Sweden, to identify bacterial co-infections in patients admitted to the ICU for COVID-19 pneumonia using the Unyvero HPN panel. High-risk COVID-19 patients, especially in intensive care units and on ventilation, many of whom may be elderly or have preexisting conditions that compromise their immune system, are at a higher risk of acquiring bacterial co-infections that pose severe life-threatening complications. These co-infections are not always easily determined based on clinical symptoms alone, and, if they go unnoticed or diagnosis is delayed, it can lead to dire outcomes including mortality. Karolinska Institutet had previously evaluated the Unyvero system and the HPN panel. Curetis has now provided additional Unyvero Analyzers for increased throughput and additional HPN cartridges to enable testing of these critical specimens. The Unyvero Hospitalized Pneumonia panel detects 21 clinically relevant pathogens and 17 antibiotic resistance markers in less than 5 hours directly from native specimen with only around 2 minutes of hands-on time, compared to routine bacterial cultures that can take up to several days for confirmatory pathogen identification and antimicrobial susceptibility testing results. In the U.S., the Unyvero LRT and LRT BAL panels for rapid detection of lower respiratory tract infections such as pneumonia are FDA-cleared for tracheal aspirate samples and bronchoalveolar lavage fluids, respectively. Unyvero HPN and LRT BAL are the only syndromic pneumonia panels that also include Pneumocystis jirovecii.
OpGen announces publication on feasibility of antibiotic susceptibility testing » 07:3504/1604/16/20
OpGen announced that a…
OpGen announced that a study on the feasibility and potential of antibiotic susceptibility testing and bacterial pathogen identification using next-generation sequencing has been pre-published in the Journal of Clinical Microbiology. The study was performed by its newly acquired subsidiaries Ares Genetics GmbH and Curetis GmbH, and scientists at the Max Perutz Labs, a joint venture of the University of Vienna and the Medical University of Vienna, and the Mayo Clinic. The article titled, "Species Identification and Antibiotic Resistance Prediction by Analysis of Whole Genome Sequence Data Using ARESdb - An Analysis of Isolates from the Unyvero Lower Respiratory Tract Infection Trial" reports on a study evaluating the performance of pathogen identification and antibiotic susceptibility testing based on whole genome DNA sequencing using Ares Genetics' AI-powered cloud-based bioinformatics platform ares-genetics.cloud and its underlying reference database, ARESdb. WGS-predicted susceptibility to antibiotics showed 89% categorical agreement with the current reference method of broth microdilution susceptibility testing across a total of 129 pathogen-drug pairs analyzed. Categorical agreement exceeded 90% in 78, and reached 100% in 32 pathogen-drug pairs. For the taxonomic identification of the isolated bacterial pathogens, WGS showed 99% and 93% concordance with the MALDI-ToF reference method at the genus and species levels, respectively. The study evaluating the AI-powered ares-genetics.cloud platform and the underlying ARESdb reference database included 12 pathogenic bacterial species and 21 antibiotic compounds covering common lower respiratory tract pathogens and is likely one of the most comprehensive peer-reviewed reports on the performance of WGS in predicting susceptibility to antibiotics in a multi-center U.S. trial. In this study, the investigators analyzed WGS data of a total of 620 bacterial strains isolated from more than 2,000 clinical samples collected from patients with suspected lower respiratory tract infections at nine hospitals across the U.S. The samples were originally collected for a U.S.-FDA study for the validation of the now FDA-cleared Unyvero LRT syndromic multiplex PCR panel by Curetis. Species identity of the isolated pathogens and their susceptibility to antibiotics were analyzed using MALDI-ToF and broth microdilution, respectively, as best-in-class reference methods according to current practice. The WGS data analysis was performed using Ares Genetics' proprietary database, ARESdb, with state-of-the-art open-source tools and public data. At the time of the study, ARESdb comprised of curated genotype-phenotype data for approximately 35,000 bacterial strains. To date, ARESdb has further grown containing matched whole-genome sequencing and antibiotic susceptibility data for more than 50,000 bacterial strains and more than 100 antibiotics. Microbial infections and antibiotic resistance have become major healthcare challenges with rapidly spreading antimicrobial resistance estimated to have caused 700,000 deaths globally in 2016, a number that is projected to dramatically increase to 10 million deaths annually by 2050 if no countermeasures are taken. At the same time, few novel antibiotics are in development and prominent pharmaceutical companies have cut back their R&D efforts in the infectious diseases space. In the absence of novel treatment options, we believe novel diagnostic approaches to allow for rapid identification of causative pathogens and their susceptibility to available treatment options are urgently needed to guide appropriate therapy of patients while enabling prudent and informed use of antibiotics. The study was supported through funding provided by the Austrian Research Promotion Agency and the Vienna Business Agency.
OpGen suspends testing, trial for Acuitas AMR Gene Panel » 07:3504/1404/14/20
Clinical trial enrollment…
Clinical trial enrollment was active during the first quarter of 2020 at all nine participating sites for the Acuitas AMR Gene Panel test. Testing and the trial have been suspended due to hospital actions to focus resources on the COVID-19 pandemic.