KL1333 on its way to registrational Phase 2/3 study⎢Ellen Donnelly appointed new CEO of Abliva.
Important events during 2020
- Positive feedback from the US Food and Drug Administration (“FDA”) and the UK MHRA, on the clinical development plan.
- Decision to conduct a cohesive registrational Phase 2/3 study starting in the second half of 2021.
- The first patients in the Phase 1a/b clinical study were dosed.
- The first healthy volunteers in the drug-drug interaction study (DDI study) were dosed.
- Preclinical pharmacology and safety studies entered the final phase.
Strategy and communications
- Change of company name to Abliva (formerly NeuroVive Pharmaceutical).
- Virtual Capital Markets Day in June.
- Mitochondria Day in September.
- Directed issue of SEK 20 million to Nordic life science investor Hadean Ventures in June. Dr Roger Franklin, partner at Hadean Ventures was elected as Director of Abliva’s Board.
- A preferential rights issue in May raised approximately SEK 67 million before deduction of issue costs.
- Magnus Persson left the Board of Directors to focus on his role as founding partner in Eir Ventures.
Important events after the reporting period
- Ellen Donnelly was appointed new CEO February 3, 2021.
- The license agreement with Fortify Therapeutics, regarding a development of a local treatment for Leber’s Hereditary Optic Neuropathy (LHON), was terminated.
- KL1333 phase 1b – seven out of eight patients have been dosed.
- New date for the Annual General Meeting – 20 May 2021.
- Net revenues: KSEK 112 (49)
- Other operating income: KSEK 1,602 (1,000)
- Loss before tax: KSEK 13,067 (27,112)
- Loss per share: SEK 0.04 (0.15)
- Diluted loss per share: SEK 0.04 (0.15)
- Net revenues: KSEK 216 (134)
- Other operating income: KSEK 1,648 (3,500)
- Loss before tax: KSEK 59,994 (77,000)
- Loss per share: SEK 0.24 (0.45)
- Diluted loss per share: SEK 0.24 (0.45)
* APM Alternative perfomance measures, see definition on page 20.
The complete Year-End report is available for download below and through the Company’s website www.abliva.com