
4
BioPorto, first nine months of 2021
Sales of antibodies, The NGAL Test and ELISA kits drives
growth
In the third quarter of 2021 revenue was DKK 5.3 million, corresponding to
a growth of 13% in USD (12% in DKK) year-over-year.
Revenue from sales of antibodies was in the quarter at the same level as
last year, whereas sales of ELISA kits increased from DKK 0.3 million last
year to DKK 1.0 million this year. Revenue from RUO sales of The NGAL Test
in the US increased 19% in USD (17% in DKK) in the third quarter of 2021
compared to last year, while ROW sales of the test in the quarter was down
DKK 0.4 million compared to last year’s DKK 0.9 million. BioPorto expects
ROW sales to regain momentum in the last part of 2021, as one single large
order has been postponed to fourth quarter 2021 as previously announced.
Revenue in the first nine months of 2021 was DKK 17.4 million, representing
a growth of 19% in USD (11% in DKK) over last year. In the first three quar-
ters of 2021, antibody sales grew 57% to DKK 7.0 million, and RUO sales
from The NGAL Test in the US increased 25% in USD (18% in DKK) to DKK
5.8 million, whereas ROW sales of The NGAL Test was DKK 2.6 million in the
period. Given the challenging global environment resulting from COVID-19,
the results were in line with the company’s expectations.
Results from Interim Analysis of Data from The NGAL Test
study are consistent with expectations
In August 2021, BioPorto concluded an interim analysis of data from the
pediatric clinical trial to evaluate The NGAL Test as a tool for risk assess-
ment of moderate to severe AKI. The study is being conducted to support a
submission to the FDA.
Based on data collected from six different leading US children’s hospitals
over a twelve-month period, the interim analysis for the clinical perfor-
mance of the assay provided results on key characteristics such as sensitiv-
ity and specificity which were consistent with expectations. The results are
expected to support the case of The NGAL Test as a biomarker to identify
risk of AKI in critical ill children.
Enrollment for pediatric trial for The NGAL Test continues,
but is delayed by COVID-19
Following this interim analysis of data from the pediatric clinical trial for
The NGAL Test, BioPorto has expanded the ongoing patient enrollment to
maximize the pediatric clinical study’s statistical power for the upcoming
FDA submission.
While the number of participating study sites has been increased to 14, en-
rollment of patients has lately been impacted and delayed by the continu-
ation of the COVID-19 pandemic which affects the health care sector as fo-
cus shifts to treatment, fewer patients are submitted to the ICU and access
for research coordinators is restricted.
Based on actual enrollment figures and the outlook on COVID-19, BioPorto
consequently revised the enrollment forecast beginning of November
2021, and now expect to finalize data collection during the first half of 2022.
After enrollment is complete, BioPorto will continue to work interactively
with the FDA to submit a De Novo Classification Request, as the NGAL Test
maintains its Breakthrough Designation status.
Testing of The NGAL Test for Emergency Use Authorization
of in relation to COVID-19 patients initiated
BioPorto has in third quarter 2021 progressed the dialogue with FDA on the
potential EUA of The NGAL Test for use in the assessment of kidney injury
and prediction of need for renal replacement therapy in COVID-19 patients.
The dialogue with FDA has been promising and BioPorto has hence initiated
testing of the original samples collected by clinical researchers at Columbia
University’s Irving Medical Center (US) and published in Kidney Interna-
tional Reports (
https://www.kireports.org/article/S2468-0249(21)01445-
5/fulltext) using The NGAL Test on a Roche analyzer.
With a reported negative predictive value of 97% in the original study,
NGAL could be an important biomarker in identifying COVID-19 patients
who have low risk of requiring renal replacement therapy and hence aid
staff in prioritizing scarce hospital resources, such as dialysis equipment
and skilled staff.
Interim data for gRAD-based Sepsis test expected in fourth
quarter 2021
The development of a gRAD-based test for the quantitative determination
of thrombomodulin in human plasma or whole blood samples which Bio-
Porto is undertaking with Rigshospitalet has further progressed in the third
quarter of 2021. The test is part of a trial evaluating the safety and efficacy
in the administration of thrombomodulin versus placebo for 72 hours in
trauma patients with hemorrhagic shock-induced endotheliopathy.
Rigshospitalet, who is leading the study, is currently summarizing the re-
sults in an interim data report, which is expected to be finalized in fourth
quarter 2021.
Results from gRAD COVID-19 test pending
The data collection for a point-of-care assay for COVID-19 continued in third
quarter 2021. Initial testing results indicate a higher sensitivity compared
to other rapid test formats.
The results are currently being evaluated and BioPorto expects to conclude
the analysis of the clinical potential before year-end 2021.
Anthony Pare appointed new CEO of BioPorto
In October 2021, BioPorto announced the appointment of Anthony (Tony)
Pare as its new Chief Executive Officer (CEO). Tony Pare joins BioPorto from
T2 Biosystems, a US Nasdaq-listed in vitro diagnostics company, where he
served as the Chief Commercial Officer and presided over several successful
product launches.
Tony has for 24 years headed product development, commercialization,
marketing and operations improvements in leading medtech and diagnos-
tic companies and delivered strong results, driving business value, increas-
ing product presence and growing sales, both in the US and globally.
Tony Pare will assume the CEO position as of November 20, 2021.