In July 2019 BioPorto announced that the FDA had requested additional information for The NGAL Test’s 510(k) application for paediatric acute kidney injury (AKI), although few other details were disclosed. Unfortunately, the existing clinical data set does not include the requested information, so the company will need to withdraw its current application and collect additional samples, which carries additional risk (probability of success lowered to 50% from 60%). The company forecasts that it will be able to refile an application in Q419 if sample collection goes smoothly.
We have very little information regarding what the FDA requested besides that it related to ‘the clinical study data and collection of retrospective samples’. This could be because certain subgroups of patients were underrepresented, the manner in which samples were collected, or a number of other possibilities. The original collection of samples had previously been tested with the NGAL ELISA test, so the results were roughly known in advance, although now this will not be the case. Thankfully, given guidance that the new data the company is gathering will also use retrospective samples, we know the request was not for a prospective trial, which would be prohibitively difficult given the indication.
The delay in the paediatric programme, although unfortunate, will not have an impact on the way forward for the adult AKI indication, the application for which is still planned to be submitted in H219 following completion of the ongoing pivotal clinical trial. Adult AKI is the primary value driver for The NGAL Test: there are over 20 times as many adult ICU patients and we additionally expect the test to enter the emergency room and post-surgical markets. The adult AKI programme is being examined in an ongoing prospective clinical study and the company is targeting a 510(k) application in the second half of 2019.
We have increased our valuation to DKK993 from DKK966m although it is lower on a per-share basis: DKK5.68 from DKK5.83 per share. The increase is driven by the recent offering (9.3m shares for DKK36.7m gross), but offset by adjustments to our paediatric AKI model. We have delayed approval to the end of 2019, added $0.5m in additional R&D expense, and lowered our probability of success to 50% (from 60%) because the new samples have not been previously examined for NGAL like the original sample set.