2020 summary
KL1333 on its way to registrational Phase 2/3 study⎢Ellen Donnelly appointed new CEO of
Important events during 2020
KL1333
- Positive feedback from the
US Food and Drug Administration (“FDA”) and theUK 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.
NV354
- Preclinical pharmacology and safety studies entered the final phase.
Strategy and communications
- Change of company name to
Abliva (formerlyNeuroVive Pharmaceutical ). - Virtual Capital Markets Day in June.
- Mitochondria Day in September.
Financials
- Directed issue of
SEK 20 million to Nordic life science investorHadean Ventures in June. DrRoger Franklin , partner atHadean 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.
Other
Magnus Persson left the Board of Directors to focus on his role as founding partner inEir Ventures .
Important events after the reporting period
Ellen Donnelly was appointed new CEOFebruary 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 .
Financial information
October-
- 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)
January-
- 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
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