May 07, 2020
Announcement no. 13
Q1 2020 Report
Highlights
Strong revenue growth of 67% for The NGAL Test
In the first quarter of 2020, BioPorto continued to experience growing global interest in The NGAL Test™, leading to a 67% increase in NGAL- related revenue – from DKK 1.3 million in Q1 2019 to DKK 2.1 million in Q1 2020.
Timeline for FDA application for The NGAL Test impacted by COVID-19
BioPorto’s primary focus in 2020 is completing the clinical study and revised application for The NGAL Test for risk assessment of pediatric acute kidney injury (AKI). During the first quarter, BioPorto’s clinical and regulatory team successfully developed the study protocol, recruited ten leading US pediatric hospital sites to participate, and held a pre-submission meeting with FDA. Despite having also completed contracting, site qualification visits, and IRB (Internal Review Board) approval for study initiation, the company was unable to begin patient enrollment due to global COVID-19 pandemic, which has paused all non-critical clinical studies across the US.
As a result, BioPorto projects that costs related to the clinical trial as well as the submission of the FDA application will be postponed to the second half of 2020.
BioPorto collaborates to develop a rapid test for COVID-19
BioPorto and the University of Southern Denmark (SDU) have entered into a partnership for co-development of a rapid COVID-19 test which will leverage the company’s patented Generic Rapid Assay Device (gRAD) technology.
Under the partnership, SDU is leading the development of SARS-CoV-2 antibodies which, deployed using gRAD, could enable point-of-care detection of the SARS-CoV-2 virus. The test is being designed to deliver results in less than 10 minutes, using a sample from an oro- or nasopharyngeal swab. If successful, a test could be available in the second half of the year.
Rights issue successfully completed, yielding DKK 38 million in net proceeds
In early April, BioPorto announced the completion of a fully subscribed rights issue and capital increase of 24,992,053 new shares at a subscription price of DKK 1.60 per share. Net proceeds of DKK 38 million from the issue, together with the company’s current cash position, will fund the clinical regulatory programs for The NGAL Test and support continued business development activities.
For further information, please contact:
Thomas Magnussen, Chairman of the Board
Ole Larsen, CFO
Telephone +45 4529 0000, e-mail: investor@bioporto.com
About BioPorto
BioPorto is an in vitro diagnostics company that provides tests and antibodies to clinicians and researchers around the world. We use our antibody and assay expertise to transform novel research tools into clinically actionable biomarkers that can make a difference in patients’ lives. BioPorto is headquartered in Hellerup, Denmark and is listed on the NASDAQ Copenhagen stock exchange [CPH:BIOPOR].
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