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Currency in USD
Last close As at 25/03/2023
USD0.17
▲ 0.04 (30.77%)
Market capitalisation
USD7m
Research: Healthcare
OpGen has completed patient sample enrollment in its prospective multicenter trial for the Unyvero urinary tract infection (UTI) panel in the United States, taking the company closer to commercializing another Unyvero test panel, following the lower respiratory tract infection (LRT) and the LRT bronchoalveolar lavage tests in 2018 and 2019, respectively. OpGen reported that more than 1,800 samples have been collected across four sites in the United States as part of the study, exceeding the FDA-recommended 1,500 samples. It expects to conclude data analysis in the next couple of months, staying on track for its planned data readout in H2’22. Positive results will be followed by FDA submission, which we expect in H123. We attribute an 80% probability of approval for the panel, which we will reassess once topline data is released.
OpGen |
Unyvero UTI panel approaching final readouts |
Clinical update |
Pharma and biotech |
4 October 2022 |
Share price performance
Business description
Analysts
OpGen is a research client of Edison Investment Research Limited |
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OpGen has completed patient sample enrollment in its prospective multicenter trial for the Unyvero urinary tract infection (UTI) panel in the United States, taking the company closer to commercializing another Unyvero test panel, following the lower respiratory tract infection (LRT) and the LRT bronchoalveolar lavage tests in 2018 and 2019, respectively. OpGen reported that more than 1,800 samples have been collected across four sites in the United States as part of the study, exceeding the FDA-recommended 1,500 samples. It expects to conclude data analysis in the next couple of months, staying on track for its planned data readout in H2’22. Positive results will be followed by FDA submission, which we expect in H123. We attribute an 80% probability of approval for the panel, which we will reassess once topline data is released.
Year end |
Revenue ($m) |
PBT* ($m) |
EPS* |
DPS |
P/E |
Yield |
12/20 |
4.2 |
(24.7) |
(1.57) |
0.0 |
N/A |
N/A |
12/21 |
4.3 |
(35.7) |
(1.17) |
0.0 |
N/A |
N/A |
12/22e |
4.6 |
(24.0) |
(0.50) |
0.0 |
N/A |
N/A |
12/23e |
7.7 |
(21.4) |
(0.44) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.
Complicated UTIs are one of the most prevalent hospital-acquired infections with a rising number of infections caused by antibiotic-resistant bacteria. The Unyvero UTI panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers (25 pathogens and 15 resistance genes) directly from native urine specimens, without the need for culturing, resulting in much quicker turnaround times (four to five hours versus days in case of culture-based tests). This is a key advantage in our opinion as early diagnosis remains crucial for effective treatment leading to more optimal usage of available antibacterial treatments, decreased hospital stays and lower healthcare costs.
The prospective multicenter clinical trial in the United States was initiated in Q321 and by June 2022, the trial had enrolled the 1,000th sample and added a fourth clinical site (in an effort to optimize enrollment). Management has communicated that enrollment completion will now be followed up by conclusion of reference testing, unblinding of data and final readout. Data analysis is expected to be completed in the next couple of months. If readouts are positive, we expect OpGen to file for FDA submission under the De Novo classification (typically takes four to six months of review time) in H123. We note that the Unyvero UTI panel is already available in the United States as a research use only product to hospitals, public health departments, clinical laboratories, pharmaceutical companies and CROs. FDA approval will drive commercial availability of the test. We attribute an 80% success probability to the UTI panel but will revisit this assumption following data readout from the trial.
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Research: Real Estate
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