BioPorto (NASDAQ COPENHAG:BIOPOR) A/S has said it is planning a rights issue to raise up to around DKK 100.4 million (US$14.7 million) to strengthen its coffers and for a clinical trial and application to the US regulator to approve its NGAL test for acute kidney injury (AKI) in children under 22.
The rights issue will be on a 1:4 basis, meaning that the company's existing shareholders will be allocated one pre-emptive right for each share held, with four pre-emptive rights required to subscribe for one new share for DKK 1.50 (US$0.22).
"We have already secured DKK 73.9 million in advance subscription commitments and guarantees from institutional investors and our three largest shareholders, including Arbejdernes Landsbank, and now look forward to presenting the offer and opportunity to our 20,000 shareholders,” said Tony Pare, BioPorto CEO in a statement.
Following potential approval by the US Food and Drug Administration (FDA) of the NGAL Test in pediatrics, the biotech said its priority includes developing its organization for potential commercialization of the test.
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The company also updated investors on the status of its NGAL test clinical trials for De Novo application to the FDA, saying the first two of three studies have been completed, and that its expects to finalize data collection for the third during the first half of 2022.
"These studies were designed based on FDA feedback from several pre-submission meetings associated with the FDA’s Breakthrough Device Designation. Our team remains focused on working with the clinical sites at fifteen leading US hospitals to complete patient enrollment by the end of Q2, 2022," noted Dr Chris Bird, BioPorto chief medical officer.
If the evaluation of the clinical trials is satisfactory, the company will submit a De Novo application to the FDA, it added.
BioPorto said it estimates revenue for 2021 of around DKK 24 million and operating earnings before interest and tax (EBIT) loss of around DKK 65 million.
Offering guidance for 2022, the diagnostics group said it forecasts revenue of between approximately DKK 24 and DKK 26 million and operating (EBIT) loss of around DKK 95 and 100 million.
To allow sufficient time to complete the contemplated rights issue, BioPorto has also postponed its annual report for 2021 and annual general meeting (AGM) to April 6 and April 28 this year, respectively. It has also revised the date for its interim report for the nine-month period to September 30 this year to November 9.
A prospectus detailing the rights issue is expected to be published shortly, the company said.
BioPorto is headquartered in Hellerup, Denmark and is listed on the NASDAQ Copenhagen stock exchange. Its flagship product is the NGAL Test, which has been designed to aid in the risk assessment of Acute Kidney Injury (ACI), a common clinical syndrome that can have severe consequences.
Contact the writer at giles@proactiveinvestors.com