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.
- 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)
- 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