OpGen Provides Business and Pipeline Update and Announces Preliminary Unaudited Revenue and Cash Position for the Third Quarter 2020
OpGentakes strategic steps to expand the Unyvero platform and product pipeline, to focus on the pending Acuitas AMR Gene Panel(isolates) FDA clearance and expects to invest significantly in bioinformatics OpGensubsidiary Ares Genetics received notification of exercise of option to negotiate for a potential future license by its IVD Partner OpGento discontinue Acuitas AMR Gene Panel(urine) clinical trial and discontinue FISH product line globally by mid-2021
- Total Revenue for Q3 2020 was approximately $1.0 million dollars
- Maintained strong balance sheet with $10.4 million cash as of September 30, 2020
In addition, the company announced details regarding a strategic reprioritization of its product portfolio, platform pipeline and priorities going forward. This reprioritization was based on feedback from extensive market research, a customer survey of 150 stakeholders in the decision making on new diagnostic platforms, and key opinion leader interviews conducted by an independent market research firm over the past two quarters. Following a review of this research,
- Product portfolio going forward to be centered around rapid, molecular diagnostic platform offerings and increased focus on value added bioinformatics solutions, including Ares Genetics’ next generation sequencing-based and artificial intelligence powered AMR and AST prediction capabilities.
- Following the successful completion of the three phases of the partnered R&D program as announced in the H1-2020 earnings call, Ares Genetics has recently received formal notification from its undisclosed global leading IVD corporation partner that they have exercised their option to exclusively negotiate with Ares Genetics the scope and terms of a potential exclusive license or other arrangement with Ares to Ares Genetics’ technology in the field of human clinical diagnostics in the coming months.
- Platform consolidation to realize significant operational synergies and cost savings over time as fewer products and platforms would need to be maintained from a regulatory, quality management and logistics and service standpoint.
- Unyvero platform and product portfolio to be expanded beyond lower respiratory tract infections such as pneumonia (LRT / LRT BAL) to include complicated urinary tract infections (cUTI) and invasive joint infections (IJI) in the
U.S.with clinical trials for future FDA submission and clearance anticipated to start in 2021. Products in both indications are fully developed and already CE-IVD marked and commercially available in Europeand other markets. Acuitas AMR Gene Panelfor Isolates expected to see near term clearance decision by the U.S.FDA after OpGen’s October 2020submission of a formal response to the FDA’s January 2020Request for Additional Information (AI) request. If cleared by the FDA, OpGenanticipates swift commercial launch in the U.S.in the following months.
- Legacy FISH products business including Quick FISH® and PNA FISH® to be discontinued by mid-2021 in
Europe, the U.S.and rest of world with last production lots to be manufactured in early 2021. Acuitas AMR Gene Panel(urine) clinical trial to be discontinued as focus shifts to Unyvero platform for complicated UTI indication as well as additional future applications.
The company also announced accomplishment of the following key milestones in the third quarter of 2020 and year to date:
- OpGen’s subsidiary
Curetis GmbHobtained CE mark certification in the European Unionfor its own SARS-CoV-2 Kit with PULB for the detection of SARS-CoV-2, the virus that causes COVID-19. OpGenannounced that subsidiary Ares Genetics GmbHwon the Austrian national digitization award and was also nominated for the 40th Austrian Innovation Award for its artificial intelligence powered, next-generation sequencing based molecular antibiotic susceptibility test marketed under the brand name ARESupa – Universal Pathogenome Assay.
- OpGen’s subsidiary
Curetis GmbHreceived EUR 350 thousandin grant funding in a collaboration project with InfectoGnostics campus at Jena University Hospital.
- OpGen’s subsidiary
Ares Genetics GmbHin collaboration with researchers from the Johns Hopkins University School of Medicine, announced the publishing of a peer-reviewed study on modifiable risk factors for the emergence of ceftolozane-tazobactam resistance in P. aeruginosa in the journal Clinical Infectious Diseases. OpGenannounced the release of a new peer-reviewed publication that demonstrates the clinical utility of the Unyvero LRT panel and its potential impact on antibiotic use in hospitalized patients with suspected pneumonia compared to treatment directed based on microbiological culture results. OpGensuccessfully completed its study collaboration with Karolinska Institutet on bacterial co-infections in COVID-19 pneumonia patients and data on the Unyvero HPN Panelwas presented by the Karolinska investigators at ECCVID 2020. OpGensignificantly improved its working capital position in the third quarter of 2020 through the sale of approximately 1.8 million shares of common stock under the company’s ATM program and the exercise of warrants from the October 2019financing for gross proceeds of $4.4 millionduring the third quarter. During the nine months ended September 30, 2020, the Company sold approximately 11.4 million shares of common stock under the company’s ATM program and upon exercise of warrants from the October 2019offering for gross proceeds of $24.4 million. The German Federal Ministry for Economic Affairs and Energy(BMWi) concluded its 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. No further action is expected from the Federal government on this matter.
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.
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This press release includes statements regarding OpGen’s third quarter 2020 results, the company’s strategic portfolio and product pipeline priorities, the ongoing integration of
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Source: OpGen, Inc.