SpectraCure AB publishes Quarterly Report 3, 2021

Third Quarter 2021

Figures for 2021 and 2020 refer to the Group.

  • Other operating income amounted to KSEK 1,249 (1,656)
  • Result after taxes amounted to KSEK -5,655 (-2,348)
  • Basic and diluted earnings per share: SEK -0.06 (-0.02)
  • Cash flow from operating activities amounted to KSEK -1,976 (-5,300)

January–September 2021

Figures for 2021 and 2020 refer to the Group.

  • Other operating income amounted to KSEK 4,520 (3,713)
  • Result after taxes amounted to KSEK -17,384 (-10,942)
  • Basic and diluted earnings per share: SEK -0.20 (-0.12)
  • Cash flow from operating activities amounted to KSEK -13,785 (-10,642).
  • Solidity: 92 (95)%

Significant events during the third quarter of 2021

There are no significant events to report.

Significant events after the end of the period

  • SpectraCure strengthened its executive management with the additions of Johan Glindre, Head of Clinical Affairs, and Johan Ingemansson, Head of Business Development. Both were already employed by the Company, and the inclusion of these roles in the executive management will increase focus on these areas that are key for the Company.
  • The organization was strengthened with a Quality Assurance Manager, who will focus on quality management with the aim of getting SpectraCures quality management system certified and ensuring that the next generation of the Company’s treatment system is compliant with the European Medical Device Regulation (MDR).
  • SpectraCure published a status update relating to the clinical trial involving treatment of patients with recurring prostate cancer. The Company intends to simplify the protocol for follow-up visits for the patients included in the trial. Travel restrictions are gradually being eased in the United States and Canada, which implies that the clinical trial may commence in North America. To accelerate the trial, we are also assessing the possiblility to recruit personnel in situ in the United States. After a meeting with University College London Hospital (UCLH), the Company concluded that UCLH is very keen to recruit patients to the trial. SpectraCure’s management and board consider that the probability of having an application for accelerated approval accepted has declined. The main reason is that the Food and Drug Administration (FDA) is deemed to have adopted a more restrictive stance with regard to accelerated approval decisions. In turn, this entails that there is a high probability that we will not receive market authorization for a product in the United States until a Phase 3 trial has been carried out successfully. It is the Company’s hope that the recruitment and treatment of patients for the Phase 2 trial will be completed in 2022. A more detailed timetable will be drawn up when the Phase 2 results are available and the Company has reached an understanding with the FDA on the design of the Phase 3 trial.
  • University College London Hospital (UCLH), the UK hospital in SpectraCure’s clinical trial, states that treatment of a patient with recurring prostate cancer is planned to be performed shortly.