Interview with CEO and CFO about development during Q1-2023
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 is a Danish in-vitro diagnostics company with headquarters in Copenhagen, Denmark. The company was founded in 2000. BioPorto has one marketed product, the NGAL test, for early diagnosis of acute kidney injury (AKI), which is commercially available in Europe, Canada, Asia, and Israel. It has received breakthrough designation from the FDA for AKI in the pediatric indication, for which it is currently conducting data analysis following the completion of enrollment of patients for its Phase 3 study which will lead to an expected application to FDA. Future plans include further FDA submission for adult indication as well as other markets.
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