"2021 was a defining year for Abliva, focused on portfolio delivering, de-risking our assets and building relationships as we prepared for success in 2022." – Ellen Donnelly, CEO
KL1333 shows signs of efficacy in patients and has an approved IND for a Phase 2/3 study
Regulatory feedback for NV354 enables clinical development
Important events during 2021
- Data from the Phase 1a/b clinical study of KL1333 were released in May and confirmed the safety and pharmacokinetic profile of the drug. In addition, in a cohort of eight patients, there were signs of efficacy across well-established relevant clinical endpoints including two patient-reported fatigue endpoints and a functional endpoint.
- The study to create a primary mitochondrial disease fatigue endpoint for use in the KL1333 Phase 2/3 study was completed in August.
- The first chronic toxicology study with KL1333 (six months) was completed in September.
- The US Food and Drug Administration approved Abliva’s Investigational New Drug (IND) application for KL1333 in November, enabling the start of a registrational Phase 2/3 study with first patients due to be recruited in 2022.
- In September, favorable feedback was received from UK pharmaceutical regulators (MHRA) on the NV354 preclinical data package.
- A directed issue of SEK 80m in two tranches was carried out in March.
- Abliva resolved on a directed issue of convertibles amounting to SEK 26m, subject to the approval of an extraordinary general meeting, in December.
- Dr. Ellen K. Donnelly, Ph.D. was appointed new CEO of Abliva.
Important events after the reporting period
- An extraordinary general meeting was held on 14 January 2022. The general meeting approved the Board of Directors’ resolution from 20 December 2021 on a directed issue of convertible bonds amounting to SEK 26 million.
- Net revenues: SEK 48,000 (112,000)
- Other operating income: SEK 126,000 (1,629,000)
- Loss before tax: SEK 36,871,000 (13,067,000)
- Loss per share before dilution: SEK 0.09 (0.03)
- Diluted loss per share: SEK 0.09 (0.03)
- Net revenues: SEK 115,000 (216,000)
- Other operating income: SEK 0,000 (1,648,000)
- Loss before tax: SEK 123,494,000 (59,994)
- Loss per share before dilution: SEK 0.33 (0.24)
- Diluted loss per share: SEK 0.33 (0.24)
* APM Alternative perfomance measures, see definition on page 20 in the report.
The complete Interim report is available for download below and through Abliva's website www.abliva.com