First quarter summary
KL1333 Phase 1a/b study completed.
Directed issue of SEK 80 million.
Important events first quarter (Jan – Mar 2021)
- Ellen Donnelly was appointed new CEO, and she will be based at Abliva Inc., in the Boston area.
- The clinical Phase 1a/b study with KL1333, Abliva’s drug candidate for chronic oral treatment of primary mitochondrial diseases, was completed. No serious adverse events (SAEs) have been reported.
- Abliva carried out a directed issue of SEK 80m, including to company lead investor Hadean Ventures. The subscription price, SEK 0.75, corresponded approximately to market price. SEK 24.5m was received immediately. 55.5 was recieved after approval at the Extraordinary General Meeting on 29 April, 2021.
- The license agreement with Fortify Therapeutics, regarding a development of a local treatment for Leber’s Hereditary Optic Neuropathy (LHON), was terminated.
Important events after the reporting period
- Positive safety and pharmacokinetic data from the double-blind, randomized, placebo-controlled Phase 1a/b study with KL1333 was reported, as well as signals of efficacy in patients with primary mitochondrial diseases. In a cohort of eight patients (six dosed with KL1333, two with placebo), there were signs of efficacy across well-established relevant clinical endpoints including two patient-reported fatigue endpoints and a functional endpoint.
- Extraordinary General Meeting was held on 29 April 2021. The Board of Director’s resolution to issue shares with deviation from the shareholder’s preferential rights was approved.
Financial information
January-March 2021*
- Net revenues: SEK 0,000 (8,000)
- Other operating income: SEK 0,000 (0,000)
- Loss before tax: SEK 21,456,000 (16,537,000)
- Loss per share: SEK 0.07 (0.10)
- Diluted loss per share: SEK 0.07 (0.10)
* APM Alternative perfomance measures, see definition on page 20.
The complete Interim report is available for download below and through the company’s website www.abliva.com