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Abliva AB Interim Report January – September 2020

KL1333 is on its way to pivotal clinical study – Pivotal study planned for the second half of 2021

Third quarter summary

Important events, third quarter (July – September 2020)

  • Abliva receives positive feedback from the US Food and Drug Administration (“FDA”) on the KL1333 clinical development plan for the treatment of primary mitochondrial disease.
  • Abliva takes the decision that the company will conduct a cohesive pivotal Phase II/III study with KL1333 starting in the second half of 2021.
  • Directed issue of SEK 20 million to Hadean Ventures completed.
  • Abliva ran a Mitochondria Day in September.

Important events after the reporting period

  • Abliva doses the first patients in the Phase Ia/b clinical study with KL1333.
  • Magnus Persson leaves the Board of Directors of Abliva AB to focus on his role as founding partner in Eir Ventures.
  • Abliva doses the first healthy volunteers in the company’s drug-drug interaction study (DDI study) with KL1333.
  • Abliva receives positive feedback from the UK MHRA on KL1333 Phase II/III study plan.

Financial information

July-September 2020*

  • Net revenues: KSEK 0 (0)
  • Other operating income: KSEK 11 (1,500)
  • Loss before tax: KSEK 10,078 (15,297)
  • Loss per share: SEK 0.03 (0.08)
  • Diluted loss per share: SEK 0.03 (0.08)

January-September 2020*

  • Net revenues: KSEK 105 (85)
  • Other operating income: KSEK 45 (2,500)
  • Loss before tax: KSEK 46,927 (49,888)
  • Loss per share: SEK 0.20 (0.30)
  • Diluted loss per share: SEK 0.20 (0.30)

* APM Alternative perfomance measures, see definition on page 19.

The complete Interim report is available for download below and through Abliva's website www.abliva.com