|Over a week ago|
OpGen's Ares Genetics announces granting of key patent in China » 07:3601/2601/26/23
OpGen and OpGen…
OpGen and OpGen subsidiary, Ares Genetics, announced the granting of a key patent by the China National Intellectual Property Administration, CNIPA. The patent with the number ZL 201680044780.7 is titled "Genetic resistance prediction against antimicrobial drugs in microorganism using structural changes in the genome" and describes the invention of a computer implemented method for the identification of genetic variations associated with antibiotic resistance in bacteria. The claims of the granted patent cover the use of bioinformatics to determine in a first step genomic differences between bacteria susceptible to antibiotic therapy and strains that are antibiotic resistant, and to identify in a second step those variants associated with AMR using statistical correlation methods. "The inappropriate and ineffective use of antibiotics is both a widespread problem in patient care and a leading driver of the silent AMR pandemic," says Dr. Arne Materna, CEO of Ares. "We believe there is an urgent need for new diagnostics to detect AMR outbreaks, particularly for healthcare associated infections, and to identify individually effective antibiotic regimen in order to reduce transmissions, improve patient care, and ultimately curb the spread of AMR. We are pleased that claims of the granted patent cover the identification and diagnostic use of genomic variants associated with AMR, and we welcome the decision by the Chinese patent office as we believe it underscores the strategic value of our IP portfolio."
OpGen sees 2022 revenue $2.7M, two est. $2.84M » 07:3401/1801/18/23
The year-end cash…
The year-end cash position as of December 31, 2022 amounted to approximately $7.4 million. On January 11, 2023, the Company successfully closed a public offering of securities raising gross proceeds of $7.5 million and net proceeds of approximately $6.8 million after deduction of placement agent commission and transaction related expenses. Oliver Schacht, President and CEO of OpGen, commented: "Despite the many challenges during 2022, we delivered on several key milestones that were planned for the year. The successful completion of our UTI clinical trial with excellent top-line data which we will now prepare for submission to the FDA, the FIND collaboration and its several milestones successfully achieved already, the launch of our ARES next generation sequencing service offerings in the U.S., and most recently, the implementation of a reverse stock split to regain compliance with Nasdaq's minimum bid price rule followed by a successful financing transaction in very challenging market conditions provide us with all of the ingredients for a strong start into 2023. The funnel of new commercial customer contracts and new accounts having begun ordering products and services from OpGen globally provide a solid foundation for revenue growth in 2023."
OpGen gets confirmation from FIND of several key milestones met » 07:4601/1701/17/23
OpGen announced that the…
OpGen announced that the Company has received confirmation from FIND, the global alliance for diagnostics, that several key milestones under its collaboration agreement with the global non-profit organization have been successfully met as of the end of 2022. This achievement has triggered an undisclosed milestone payment per the terms of the agreement.The completed milestone included several key deliverables: successful demonstration of DNA isolation on the Unyvero A30 cartridge from representative bacterial strains in various types of blood culture bottles with subsequent PCR; successful demonstration of several 3-plex assays from the intended panel on the A30 cartridge with both pathogen detection as well as AMR markers; and a detailed set of product requirements for the target product profile, including a list of analytes to be detected which has been defined. OpGen's subsidiary Curetis furthermore provided a report including results from its internal database analysis looking at genetic diversity and resistance profiles in pathogens observed in low and middle income countries. Also, a device specification for a prototype cockpit optimized for use with the A30 platform has been defined and agreed upon.
|Over a month ago|
OpGen announces 1-for-20 reverse stock split » 16:3501/0401/04/23
OpGen announced that the…
OpGen announced that the company's board of directors has approved a 1-for-20 reverse stock split of its shares of common stock. The Reverse Stock Split will become effective at January 5 and the company's common stock will open for trading on Nasdaq under the company's existing trading symbol (OPGN).
OpGen announces data from trial for Unyvero Urinary Tract Infection Panel » 07:3412/1312/13/22
OpGe announced top line…
OpGe announced top line data from its successfully completed Unyvero UTI clinical trial. OpGen's Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from urine specimens. The test aims at quantitative detection of microorganisms. The trial was designed to compare the performance of the Unyvero UTI Panel for detecting urinary tract infections, UTI, using clean-catch or catheter related urine samples. Preliminary analysis of all prospectively enrolled samples showed that the primary study endpoint was successfully met by demonstrating an overall weighted average sensitivity of 96.4% and overall weighted average specificity of 97.4% when compared against each trial site's standard of care microbiology results. The trial included a total of 1,858 prospective and archived samples and has run over 3,300 Unyvero cartridges, including controls and reproducibility tests performed at the different trial sites. In addition to local microbiology laboratory results and additional standardized central microbiology data from an independent reference laboratory, OpGen is currently generating next-generation sequencing data at its Rockville, MD, lab facility to also allow genotypic correlation of antibiotic resistance markers detected during the study. Based on the results of the unblinded data set, testing of additional contrived samples with well-characterized pathogen strains will complement and provide additional data points for low prevalence strains and antibiotic resistance markers. Based on all the data generated and analyzed, OpGen will now start preparing a De Novo request package for submission to the U.S. FDA in due course.
|Over a quarter ago|
OpGen reports preliminary Q3 revenue $0.4M vs $1.2M last year » 07:3710/2710/27/22
Cash as of September 30,…
Cash as of September 30, 2022 was approximately $10.3 million and as of October 3, 2022 was approximately $13.3 million. CEO Oliver Schacht commented, "We have seen a decrease in revenue in Q3 2022 compared to last year's third quarter due to the completion of the New York State Department of Health project in Q3 last year, and lower than expected ARES sales. Our preliminary quarterly results do not reflect the potential impact from the FIND collaboration agreement, which is expected to culminate with a series of milestones and deliverables at the end of Q1 2023. Acuitas sales are not reflected in the third quarter numbers at a material level either, since the first couple of sites became operational with completed systems installations and trainings in October. We have been informed by Beijing Clear Biotech's regulatory advisors about NMPA feedback regarding our Unyvero A50 pneumonia product which would require us to re-submit in China under a new electronic filing regime. We are in dialog with them to gain further insights and assess the potential impact on the overall process and timelines and will provide an update as soon as practicable."
OpGen subsidiary Curetis, BioVersys sign collaboration agreement » 07:3710/2510/25/22
OpGen and BioVersys AG…
OpGen and BioVersys AG announced the signing of a collaboration agreement for the deployment and use of the Unyvero platform in BioVersys' upcoming Phase II clinical trial of novel drug candidate BV100. In the planned Phase II clinical trial, hospital sites will be using the Unyvero HPN for hospitalized pneumonia patients as a rapid diagnostic test to help optimize enrollment. The Curetis team will train a team of trainers at BioVersys and their clinical research organization for the Phase II trial. BioVersys will rent the Unyvero systems for the duration of the trial and will purchase the pneumonia cartridges and all consumables for the rapid diagnostics from Curetis. Oliver Schacht, PhD, Chief Executive Officer of OpGen Inc. added: "The entire OpGen and Curetis team is excited to begin our collaboration with BioVersys and support their Phase II clinical trial of BV100 with our Unyvero platform. With Unyvero being the first to market CE IVD marked and FDA cleared sample to answer platform to offer a comprehensive and uniquely differentiated pneumonia panel and the broadest panel of AMR markers, we believe that there will be significant value added to patient selection and enrollment into the trial. It adds to the growing body of clinical evidence demonstrating the benefits of rapid pneumonia testing in hospitalized patients, also for pharmaceutical and biotech companies and their clinical trials."
OpGen announces completion of trial enrollment for Unyvero UTI Panel » 07:3210/0310/03/22
OpGen announced its…
OpGen announced its completion of patient enrollment for its clinical trial for the Unyvero Urinary Tract Infection Panel. OpGen's Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from native urine specimens. OpGen had recently added a fourth study site in the U.S. to optimize enrollment for different urine sample types to be included in the study, which enabled successful collection of over 1,800 urine samples. Given the complexity and comprehensive nature of the data sets, OpGen expects to conclude data analysis in the next couple of months. Unblinded data for each patient sample will comprise Unyvero UTI Panel results, standard of care microbiology from the clinical trial sites, as well as additional standardized central microbiology data from a reference laboratory.
OpGen announces $3.38M registered direct offering » 08:4009/3009/30/22
OpGen entered into a…
OpGen entered into a securities purchase agreement with a single institutional investor for the purchase and sale in a registered direct offering of 9,660,000 shares of the Company's common stock, 33,810 shares of Series C mirroring preferred stock and, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 9,660,000 shares of common stock, at a purchase price of $0.35 per share. Each share of Series C Preferred Stock has a stated value of $0.01 per share and will automatically terminate on the date that the Company effects a reverse stock split of the Company's shares of common stock. The warrants have an exercise price of $0.377 per share, will become exercisable six months following the date of issuance and will expire five and one-half years following the date of issuance. The closing of the offering is expected to occur on or about October 3, 2022, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The Company expects to call a special meeting of stockholders for the approval of a proposal to effect a reverse stock split of the Company's common stock. The Series C Preferred has voting rights on the Proposal equal to 100,000 votes per share of Series C Preferred, provided that any votes cast by the Series C Preferred with respect to the Proposal must be counted by the Company in the same proportion as the shares of common stock voted on the Proposal. Total gross proceeds from the offering, before deducting the placement agent's fees and other estimated offering expenses, is expected to be approximately $3.38 million. The Company intends to use the net proceeds from this offering to: continue commercialization of the FDA-cleared Acuitas AMR Gene Panel test for isolates in the U.S.; commercialize our other products with a focus on the Unyvero platform and diagnostic tests; support further development and commercialization of the Ares Genetics database; support directed sales and marketing efforts to the customers and collaborators for our products and services; invest in manufacturing and operations infrastructure to support sales of products; and the repayment of certain outstanding indebtedness of the Company. OpGen intends to use the remaining net proceeds for working capital and other general corporate purposes.
OpGen subsidiary Curetis, FIND sign R&D collaboration agreement » 07:3309/2009/20/22
OpGen announced the…
OpGen announced the signing of an R&D collaboration agreement with FIND, the global alliance for diagnostics, for the Unyvero A30 RQ platform for use in rapid pathogen ID and AMR testing from blood culture samples in low and middle income countries, LMICs. The Unyvero A30 RQ platform is a sample to answer instrument running a disposable one-time use cartridge that can test for up to 33 diagnostic targets from a single specimen. Oliver Schacht, President & CEO of OpGen, commented, "We are excited to partner with FIND, in demonstrating that our Unyvero A30 RQ platform is ideally suited to being used in LMICs for rapid detection of AMR which is a truly global issue that must be addressed in a multilateral and indeed global fashion. The R&D contract and associated funding will support the required R&D efforts on our side and expedite such development." If successful, after demonstrating feasibility and completing this initial R&D project phase, both parties have agreed to discuss the option of a potential future collaboration and commercialization agreement between OpGen and FIND.