OpGen Provides Business Update and Announces Preliminary Unaudited Revenue and Cash Position for Second Quarter 2020
- Preliminary Total Revenue for Q2 2020 was approximately
$1.2 million dollars
- Balance sheet strengthened significantly with
$6.1 millioncash raised in Q2 2020
The company also announced accomplishment of the following key milestones in the second quarter of 2020 and year to date:
OpGenannounced a strategic co-promotion partnership with Menarini Silicon Biosystemsto market and sell Menarini’s CELLSEARCH system, CELLSEARCH CEC kit and COVID-19 related products to infectious disease healthcare providers and researchers in North America;
- OpGen’s subsidiary
Curetis GmbHsecured access to an additional EUR 5 milliontranche in non-dilutive debt financing for COVID-19 related research and development. Subject to certain conditions, Curetis can draw down the tranche at its sole discretion during a nine-month period and the tranche will have a five-year maturity and is interest-only until then;
- Preliminary data was released from an investigator-initiated collaboration with Karolinska Institutet,
Stockholm, Sweden, to identify bacterial co-infections in hospitalized patients with COVID-19 pneumonia. OpGen’s Unyvero HPN Panelfor Pneumonia identifies life-threatening bacterial co-infections in COVID-19 patients in just five hours, and Unyvero LRT and LRT BAL panels are FDA-cleared in the U.S.for rapid detection of lower respiratory tract infections such as pneumonia. Furthermore, performance of the Unyvero system was highlighted in several posters and abstracts in ASM Microbe 2020 online; OpGenexpanded their partnership with the New York State Department of Health and IDC(Infectious Disease Connect), to continue the collaborative program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions statewide. In response to the COVID-19 pandemic in New York State, testing under the program was put on hold by the Wadsworth Center and participating hospitals during Q2 with sites expecting to begin running tests again in Q3; OpGenannounced results from a study on the feasibility and potential of antibiotic susceptibility testing and bacterial pathogen identification using next-generation sequencing (NGS) have been pre-published in the Journal of Clinical Microbiology. The study was performed by OpGen’s recently acquired subsidiaries Ares Genetics GmbHand Curetis GmbH; OpGenexpects that its submission to the U.S. Food and Drug Administration(“FDA”) for clearance of the Acuitas® AMR Gene Panel(Isolates) for the detection of antimicrobial resistance genes in bacterial isolates is nearing completion. OpGenhas responded, and is continuing to respond, to the FDA’s additional information requests and anticipates approaching a clearance decision for the Acuitas® AMR Gene Panelfor isolates; exact timing cannot be projected due to the COVID-19 pandemic. As a result of the COVID-19 pandemic, the FDA has granted a 90-day extension to marketing submissions and applications on hold as of June 2020, which resulted in OpGen’s original submission deadline of July 15, 2020 being extended to October 13, 2020;
- Clinical trials were initiated during the first quarter of 2020 at nine participating sites for the Company’s
Acuitas AMR Gene Panel(Urine) test. Testing and the trial have been suspended during most of the second quarter of 2020 due to hospitals focusing resources on the COVID-19 pandemic, however, a number of sites have re-initiated enrollment at the end of the second quarter; OpGensignificantly improved its working capital position in the second quarter of 2020 through the sale of approximately 2.7 million shares of common stock for gross proceeds of $6.1 millionunder the company’s ATM program during the second quarter. During the six months ended June 30, 2020, the Company sold approximately 5.6 million shares of common stock for gross proceeds of $11.9 millionunder the company’s ATM program; and The German Federal Ministry for Economic Affairs and Energy(BMWi) initiated an investigation of the OpGenbusiness combination with Curetis with regards to its impact on the public order and security of the Federal Republicof Germany as well as national healthcare interests in the light of the current COVID-19 pandemic. OpGenhas already responded to all questions currently raised by the BMWi and will remain in constructive dialogue with the BMWi with a view to completing the process as swiftly as possible.
The preliminary financial results are estimates prior to the completion of OpGen’s financial closing procedures and review procedures by its external auditors and therefore may be subject to adjustment when the actual results are available.
For more information, please visit www.opgen.com.
This press release includes statements regarding OpGen’s second quarter 2020 results, the integration of
President and CEO
OpGen Press Contact:
FischTank Marketing and PR
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Source: OpGen, Inc.