Currency in USD
Last close As at 04/02/2023
USD0.17
▲ 0.04 (30.77%)
Market capitalisation
USD7m
Research: Healthcare
OpGen has announced encouraging final data from its Unyvero Urinary Tract Infection (UTI) panel, a diagnostic test designed to detect pathogens and antimicrobial resistance markers related to UTI, from native urine specimens without the need for culturing. The study, which recruited over 1,800 patient samples across four trial sites in the United States, met its primary endpoint with an overall weighted average sensitivity of 96.4% and specificity of 97.4% in preliminary analysis. The favourable data should support an FDA De Novo application, which we anticipate in Q123 followed by likely launch in 2024, provided FDA clearance is received. The company also plans to submit the data for a peer review publication, which we believe would further strengthen the credibility and visibility of the UTI panel. We see this development as supporting potential test menu expansion for the company’s flagship Unyvero systems in the United States. The market has reacted positively to this news with the stock closing 85% higher in trading.
OpGen |
Test menu expansion opportunity with positive data |
Clinical update |
Pharma and biotech |
14 December 2022 |
Share price performance Business description
Analysts
OpGen is a research client of Edison Investment Research Limited |
OpGen has announced encouraging final data from its Unyvero Urinary Tract Infection (UTI) panel, a diagnostic test designed to detect pathogens and antimicrobial resistance markers related to UTI, from native urine specimens without the need for culturing. The study, which recruited over 1,800 patient samples across four trial sites in the United States, met its primary endpoint with an overall weighted average sensitivity of 96.4% and specificity of 97.4% in preliminary analysis. The favourable data should support an FDA De Novo application, which we anticipate in Q123 followed by likely launch in 2024, provided FDA clearance is received. The company also plans to submit the data for a peer review publication, which we believe would further strengthen the credibility and visibility of the UTI panel. We see this development as supporting potential test menu expansion for the company’s flagship Unyvero systems in the United States. The market has reacted positively to this news with the stock closing 85% higher in trading.
Year end |
Revenue ($m) |
EBITDA* ($m) |
PBT* ($m) |
EPS* |
P/revenue |
P/E |
Net debt |
12/20 |
4.2 |
(19.6) |
(24.7) |
(1.6) |
3.0 |
N/A |
6.7 |
12/21 |
4.3 |
(20.4) |
(35.7) |
(1.0) |
2.9 |
N/A |
(14.4) |
Note: *EBITDA, PBT and EPS are normalised, excluding amortization of acquired intangibles, exceptional items and share-based payments.
The UTI clinical trial, initiated in Q321, was conducted on 1,858 prospective patient samples across four US sites with over 3,300 Unyvero UTI cartridges used, including for controls. The primary objective was to test the effectiveness of the Unyvero UTI panel in identifying urinary tract infections using clean-catch or catheter-related urine samples. The primary endpoint was met with overall weighted average sensitivity and specificity of 96.4% and 97.4%, respectively, when compared with the trial sites’ standard of care microbiology results.
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 the case of culture-based tests). This is a key advantage in our opinion as early diagnosis remains crucial for effective treatment and should lead to more optimal usage of available antibacterial treatments, decreased hospital stays and lower healthcare costs.
OpGen plans to file for FDA submission under the De Novo classification, which we anticipate in Q123. In parallel, the company is also working on next-generation sequencing data at its Rockville (US) laboratory to study genotypic correlation of antibiotic resistance markers identified in the study, which will generate additional data for low prevalence strains and antibiotic resistance markers. We view the FDA clearance as likely, which would further validate the company’s Unyvero platform. 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.
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Research: Healthcare
Respiri continues to advance its commercialisation plans for wheezo with the recent initiation of patient onboarding for the Minnesota Lung Center’s (MLC’s) pilot programme. We note that the shortened timeline for the pilot study (reduced from three to two months) bodes well for the broader roll-out of wheezo as part of MLC’s standard solutions for management of asthma and chronic obstructive pulmonary disease (COPD) patients. We believe this engagement to be particularly meaningful for Respiri, given MLC’s focus on respiratory diseases, and see a potential long-term collaboration as providing impetus to wheezo’s commercialisation efforts. Our valuation remains unchanged at A$0.24 per share.
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