Interview with CEO Tony Paré and CFO Neil Goldman about first quarter 2023 results and highlights.
As usual the management gave a confident and focused presentation delivering a strong message that the dialogue with FDA is on track to obtain a marketing authorization for its NGAL-test for pediatrics in US Intensive Care Units settings following the application submitted to FDA in November 2022. FDA has requested additional information, but this is to be expected in such processes according to management, and hinted that it relates to formalities and clarification of how trial data is structured etc.
At the event, management also shared insights and perspectives on the likelihood and potential for a pediatric approval to lead to an approval the NGAL-test for adult use as well as for use in other settings, making room for a significant expansion of the addressable market of up to USD 3 billion annually. Lastly, CFO Neil Goldman detailed how the company continuously monitor and consider the opportunities to raise additional capital. To get a better understanding of BioPorto and get the latest update, please see the event at the following link: https://www.inderes.dk/videos/bioporto-presentation-of-q1-2023
Disclaimer: HC Andersen Capital receives payment from BioPorto for a DigitalIR/Corporate Visibility agreement. /Claus Thestrup 09:15 AM 12th of May 2023.
BioPorto
BioPorto er et dansk In-vitro diagnostisk (IVD) selskab med hovedkontor i København, Danmark. Selskabet blev grundlagt i 2000. BioPorto har allerede ét produkt på markedet, NGAL-testen, som er til tidlig diagnosticering af akutte nyreskade (AKI). Den er kommercielt tilgængelig i Europa, Canada, Asien og Israel. NGAL-testen har modtaget banebrydende betegnelser fra FDA for akutte nyreskader til babyer, børn og unge under 18 år for hvilken den i øjeblikket udfører dataanalyser efter afslutningen af indrulning af patienter til dets fase 3-studie, som vil føre til en ansøgning til FDA. Fremtidige planer inkluderer yderligere FDA-indsendelse til voksenindikation såvel som andre markeder.
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