Calmark comments on the effects from COVID-19 and announces updated timetable for clinical trial at Södersjukhuset
Calmark Sweden AB announces today that the timetable for the clinical trial at Södersjukhuset with the Company's first product, Neo-Bilirubin, has been updated. All infants have still not been included, and given the current circumstances, it is difficult to predict when it will be possible to finish the study. Nevertheless, the work is progressing at the best possible pace. Once the last infant has been included, the remaining step before Neo-Bilirubin can obtain its CE mark is the preparation of final reports, which is projected to take approximately two weeks.
Up until now, Calmark's development project has not been negatively impacted by the COVID-19 outbreak. Thus far, the CE conformity marking process and the development of the Company's first product, Calmark Neo-Bilirubin, have proceeded according to the timetable presented on 28 January. With the current situation, healthcare in general is heavily strained; it is therefore difficult to assess today how reprioritizations and reorganizations will affect the Company and the study.
"In view of the CE marking, we have finished those parts that we can do internally in our development department. We have also prepared most of the regulatory documentation that is required – and we are now waiting for the SÖS study to be concluded," says Anna Söderlund, CEO of Calmark. "The healthcare situation is very precarious, and we must adjust our expectations to the extraordinary conditions. Remarkable efforts are being made and we trust that priority is given to the right areas."
At present, it is difficult to assess the consequences of COVID-19 for the Company, both with regard to the outbreak itself and the decisions that follow in its wake.
Due to travel restrictions and difficulties in performing demonstrations in healthcare units and meetings such as the POC testing conference PNA-dagarna, temporary modifications have been made to the Company's sales process. This may affect the pace of the market launch. Calmark's liquidity is abundant for the time being thanks to the directed rights issue which was carried out in December 2019.
This information is information that Calmark Sweden AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 14:00 CET on 26 March 2020.
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.