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BioPorto focused on flagship NGAL acute kidney-injury test but also looking at coronavirus test

Snapshot

The US-listed Danish company is seeking FDA approval of the NGAL test for use in children and eventually adults

human kidneys

Quick facts: BioPorto

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OTC:THOXF

Price: 0.75 USD

Market Cap: $200.82 m
  • Proprietary NGAL Test provides early risk assessment of acute kidney injury (AKI)
  • Test available for diagnostic use in Europe and Canada but not in the US yet
  • Moving ahead with its Danish partner on co-development of a rapid test to detect coronavirus

What BioPorto does:

BioPorto A/S (CPH:BIOPOR) is an in-vitro diagnostic company based in Hellerup, Denmark, that provides health-care professionals in 80 countries a range of diagnostic tests and antibodies to treat obesity and diabetes, innate immunity, allergies and infectious diseases. 

The Copenhagen-listed company, founded in 2000, has been aggressively marketing its proprietary NGAL Test, which provides an early risk assessment of acute kidney injury (AKI), a well-known complication that is common after surgeries such as kidney transplants and heart-bypass.

BioPorto says its NGAL Test can detect AKI in critically ill patients as quickly as 2 hours. It is the only AKI biomarker that can be measured in both human urine and plasma and can run on standard chemistry analyzers.

The NGAL Test helps doctors tailor a care plan more quickly and effectively than standard testing, which reduces the risk of renal failure and/or death. The test measures NGAL levels, a biomarker which increases in response to injury. The company says rival tests can take up to 72 hours to detect injury to the kidney.

Aside from the test, BioPorto has an established business selling antibodies globally. The company offers more than 400 monoclonal antibodies, which are types of lab-created proteins that can bind to substances in the body, including cancer cells. The antibodies are made by identical immune cells that are all clones of a unique parent cell. The antibodies are used in research disciplines.

Recently, BioPorto also partnered with the University of Southern Denmark (SDU) to co-develop a test for early, rapid detection of SARS-CoV-2, the virus that causes coronavirus ((COVID-19). The test is designed to use novel SDU antibodies with BioPorto’s patented gRAD technology to create a dipstick point-of-care test that can detect the SARS-CoV-2 virus from a sample in under 10 minutes.

How is it doing:

It has been all change in the BioPorrto boardroom in 2021. On May 5, the company announced that its chief executive officer of nearly eight years, Peter Mørch Eriksen, will resign his position with the company once his successor has been found. Mørch Eriksen, however, will continue to support the company until the end of January 2022, the company said.

 And just over a week earlier, BioPorto had announced that it has begun a search for a new CFO after Ole Larsen resigned to pursue opportunities outside the company.  Larsen had served as CFO and a member of the company’s management team since 2018. He will officially leave the company by the end of May and remain available for the company until the end of October.

Looking at financials, on May 12 BioPorto shared an interim report which showed that its first-quarter 2021 revenue grew by 33% driven by “strong sales of antibodies” and its flagship NGAL acute kidney-injury test.  The in-vitro diagnostic company based in Hellerup, Denmark, said that revenue from product sales of its proprietary NGAL Test remained at last year’s “high level” with a “solid performance” in the United States.

Based on results in the first quarter, the Danish company forecast overall revenue of approximately DKK 30 (US$4.9 million) for 2021, which was the same as the financial guidance for the year that BioPorto had published in its 2020 Annual Report on March 17.

In that March report, BioPorto had said the number excluded revenues from potential sales of a COVID-19 lateral flow test, and with only early sales from a US Food & Drug Administration (FDA) cleared NGAL kidney test product for pediatrics. The company had also said then it expects an EBIT loss of approximately DKK 73 million (around US$11.7 million).

The company said the main growth driver in 2021 will be product sales of The NGAL Test in the European Union and the Rest of the World, while sales of antibodies and ELISA kits are expected to continue to decline due to BioPorto’s strategic refocus on products generated from its own antibody library. As has been the recent pattern, 2021 revenues will be back-end loaded, it added.

In 2020, the coronavirus (COVID-19) brought significant challenges in patient enrollment, as hospitals were forced to prioritize patient care over clinical research. Subject to the developments of the pandemic during 2021, BioPorto, therefore, expects to conclude its study in the summer of 2021 and thereafter submit its application on pediatric use of The NGAL Test to the FDA.

The company's COVID-19 test based on gRAD is also currently being tested with patient samples in the US. If successful, BioPorto plans to request an emergency use authorization in the US and a CE mark in Europe in the second quarter of 2021, Eriksen said.

On March 3, 2021, BioPorto had said it expects to complete its clinical study and submit a De Novo application to the US Food & Drug Administration (FDA) for pediatric use of its NGAL kidney test this summer.

The Danish company also said it is awaiting US test results for the rapid gRAD-based SARS-CoV-2 assay; if positive, and will then proceed towards US FDA Emergency Use Authorization (EUA) and European CE mark submissions in the second quarter of 2021. To further support the CE mark application, BioPorto said it is also evaluating options for conducting additional testing at clinical sites in Europe.

At the end of 2020, BioPorto Diagnostics revealed it has gained the CE mark in Europe for its NGALds test, the first based on the group's proprietary Generic Rapid Assay Device (gRAD) platform for the development of lateral flow assays.

The NGALds test is designed to deliver a semi-quantitative NGAL (neutrophil gelatinase-associated lipocalin) result in under 15 minutes, without the need for laboratory instrumentation or complex user training. This makes it ideal for near-patient settings such as physician offices and urgent care clinics, where a quick assessment of the risk of kidney injury can help clinicians to better triage patients.

As an outpatient test, it will complement in-patient hospital use of BioPorto’s automated assay, The NGAL Test. The group said the commercial launch of the NGALds test will be initiated immediately in Europe through BioPorto’s distribution partners and the company’s sales team. At a later stage, BioPorto plans to seek regulatory approval of the test in other markets, it added.

In parallel with the development of NGALds, BioPorto said it has also implemented an accelerated gRAD development process to create a rapid test for the SARS-CoV-2 virus which causes coronavirus (COVID-19). The goal is to offer a simple test that can quickly and accurately identify infected patients using a non-invasive sample, delivering a result in under 15 minutes, at a price significantly less than molecular tests.

After completing successful antibody pairing, device prototyping and production agreements, on December 23, 2020, BioPorto said it provided test kits to the University of California, Davis in the US to test samples from approximately 150 COVID-19 patients.

BioPorto said in September that its fast-track collaboration with the University of Southern Denmark (SDU) to create a 10-minute test for the coronavirus (COVID-19) had yielded promising results in tests against heat-inactivated virus.

The collaboration, announced in April, leverages SDU’s antibody expertise and BioPorto’s Generic Rapid Assay Device (gRAD) platform for the development of lateral flow assays to develop a non-invasive rapid test for SARS-CoV-2, the virus that causes COVID-19. 

The SARS-CoV-2 antibodies are highly specific to the virus’s spike protein, which could result in a higher clinical specificity compared to other commercially available rapid tests.

Inflection points:

  • Search for new CEO and new CFO
  • Commercialization in Europe of its NGALds test
  • US FDA approval of the NGAL Test for pediatrics 
  • Collect data to support the submission of adult application for the test 
  • More news on rapid coronavirus test development

What the broker says:

In a note published on May 13, 2021, following BioPorto's first-quarter results, analysts at Edison Research noted: "BioPorto is facing a major turning point as it continues the enrolment of its pivotal study of paediatric AKI. The study is using NGAL measured in urine to gauge the risk of AKI in paediatric patients, and the company recently guided towards the study being completed in summer 2021.

"BioPorto expects to file an application for De Novo 510(k) clearance shortly thereafter. Moreover, this study and the results of the application will inform how the company will pursue clearance for the adult NGAL Test, which is expected to progress after the FDA response."

The analysts also noted that the company announced two departures from its C-suite in Q221 with both the company’s CEO and CFO will be moving on from the company.

They concluded: "Our valuation is up slightly: DKK916m from DKK909m previously, and DKK3.42/share from DKK3.41/share. This does not include the contribution from the COVID-19 program, as in previous reports. Our valuations increased from rolling forward our NPVs, but this was offset by lower net cash (DKK91.1m pro forma following recent warrant exercises from DKK108m at the end of Q420)."

What the boss says:

In the company's first-quarter revenue statement on May 12, BioPorto CEO Peter Mørch Eriksen said: “Viewed in the light of a quarter still heavily influenced by the severity of the global third wave of coronavirus (COVID-19), I am satisfied with BioPorto’s performance. We drove revenue up by more than 30% by utilizing all of our assets, despite limited access to key markets for key products.”

“In this context, I believe maintaining revenue from product sales of the NGAL Test at last year’s high level is a solid achievement and I am glad to see our own library of antibodies performing very well,” he added.

Contact the author at jon.hopkins@proactiveinvestors.com

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