OpGen is a diagnostic company focused on revolutionizing the identification and treatment of bacterial infections. The Acuitas AMR Gene Panel molecular test, in combination with the Acuitas Lighthouse bioinformatics product, allows for the detection of five pathogens as well as 47 resistance genes and mutations, while also predicting the resistance for 14 antibiotics in less than three hours, a major improvement over the two to three days current methods require. OpGen expects to initiate the 510(k) clearance processes for its products in Q219.
It currently takes days to test a patient sample to find out if they have an infection, what they are infected with and to which drugs that infection might be susceptible. This can lead to a delay in treatment or the wrong treatment being prescribed. According to the Centers for Disease Control and Prevention (CDC), there are over two million cases of drug-resistant bacterial infections every year, so identifying the correct treatment is more important than ever
In less than three hours, OpGen’s system can do what current systems take two to three days to achieve. The company will first file for approval for testing in bacterial isolates in early Q219, then follow up with an application to test directly from urine samples in Q419 and another for its Lighthouse software in H219. It will first focus on complicated urinary tract infections (cUTI), of which there are around one million cases per year.
OpGen announced a collaboration with the New York State Department of Health and Merck’s ILUM Health Solutions to develop a tool to track infectious disease and antimicrobial resistance across New York State. Through this agreement, OpGen will gain access to hospitals across New York, which will increase product penetration. The company will receive $1.6m over the first 12 months during the demonstration portion, with full implementation expected over the next five years.
We arrive at a valuation of $47.3m or $2.68 per basic share (post Q119 equity offering), driven mainly by the Acuitas AMR Gene Panel and Lighthouse products. Key valuation inflection points over the next 12–18 months will be FDA 510(k) clearances for both key products as well as the subsequent commercial launch. We expect the company to require $41m in financing before profitability in 2023.