In July 2019, the FDA requested additional information (AI) relating to ‘the clinical study data and collection of retrospective samples’, which could have been due to underrepresentation of certain subgroups, the manner of sample collection, or a number of other possibilities. The company initially guided the need to withdraw and resubmit its application; however, after conducting a thorough review and a productive dialogue with the FDA, BioPorto decided to respond to the AI letter in October 2019. The FDA’s conclusion is expected by year end since BioPorto’s response to the AI continues the 510(k)-clearance process, whereas a withdrawal and re-submission would have pushed back the overall timeline into 2020.

The brief delay in the paediatric programme will impact on the adult AKI indication timeline as submission is expected by year end following the completion of the ongoing pivotal clinical trial. Since there are over 20 times more adult intensive care unit (ICU) patients than paediatric, the adult indication is the primary value driver for The NGAL Test and we also expect the test to enter follow-on indications, such as the emergency room and post-surgical markets. Continued enrolment is expected to include an additional 150–200 patients to supplement the clinical data in the 510(k) application and, upon FDA clearance, the company will commence commercialisation via its own salesforce and its distribution partners, Roche and Siemens. 

We have not changed our valuation, which sits at DKK993m (DKK5.67 per basic share). We no longer anticipate a paediatric timeline delay, so we removed the clinical trial and associated expenses. Our expected commercialisation timeline has been pushed back by six months and we project that the company will need to raise DKK35m to reach sustainable profitability in 2021.