AroCell AB (publ) Interim Report January 1st to Mars 31st, 2021

A word from the CEO
”I have now had the privilege of being the CEO of AroCell for "100 days". It has been and is an incredibly fun, intense, and eventful period. We have strengthened our organization, worked with commercialization in the United States. The FDA has resumed processing our 510(k) application. In more detail, we have expanded our clinical team, worked with the initiation of new clinical studies, and in addition to this, we have also recently submitted a public takeover bid for IDL Biotech AB. We see the merger with IDL as a unique opportunity for both companies to further develop the joint product portfolio and increase sales.”

Anders Hultman, CEO

Reporting period January 1st - Mars 31st

  • Net sales were 43 (64) KSEK
  • Loss before financial items was -6 078 (-5 474) KSEK
  • Cash flow from operating activities was -6 235 (-5 068) KSEK
  • Earnings per share before and after dilution were -0.08 (-0.08) SEK
  • Cash and cash equivalents were at the end of the period 35 778 (55 847) KSEK

Events during the reporting period January 1st - Mars 31st

  • Anders Hultman, the company's CFO, was appointed new CEO of Arocell. Former CEO Michael Brobjer has resigned at his request but will remain in the company until April 30 as CCO.
  • AroCell announced that Jonas Söderholm has been recruited to the management team as Global Medical Lead. Jonas will lead and develop AroCell's clinical program with a focus on obtaining more clinical evidence for the use of TK1 as a biomarker in cancer treatment.
  • FDA informs about further delays. The COVID-19 pandemic has led to the redeployment of FDA personnel, leading to further delays in reviewing FDA applications. The delay is extended by another 90 days.
  • Gunnar Steineck was appointed as Chief Medical Officer at AroCell. Gunnar has until now been interim CMO but now has the role permanently. Gunnar has extensive experience as both an oncologist and clinical researcher.
  • The FDA announced that they will resume the review of the AroCell 510(k) application by April 15, 2021.
  • Staffan Eriksson joins AroCell's advisory board and thus leaves his position as CSO.
  • The Nomination Committee proposed that AroCell's Board of Directors be expanded with one member at the 2021 Annual General Meeting through the election of Lotta Ljungqvist.

Events after the reporting period

  • AroCell submitted a public takeover bid to the shareholders of IDL Biotech AB
  • The FDA announced in April that they have resumed the review of AroCell's 510(k) application following the impact of relocation due to the COVID-19 pandemic.
  • A recently published doctoral dissertation deepens the knowledge about early detection, course, and prediction of treatment effects in prostate cancer. One of the sub-works in the dissertation examines the extent to which the concentration of the enzyme Thymidine kinase 1 (TK1) in the blood can be used to predict whether the patient will die of prostate cancer.

Interim report January 1st - Mars 31st, 2020 (available in Swedish only) (Link)