Abliva AB Year-End Report January – December 2023

40 Patients Enrolled in Wave 1 of the FALCON Study | Fast Track Designation for KL1333 | Orphan Drug Designation for NV354 in both US and Europe

2023 Summary

Important events during 2023


  • The first patient in Abliva’s global, potentially registrational, clinical Phase 2 study – the FALCON study was dosed in June.
  • Fast Track designation was received in September from the U.S. Food and Drug Administration (FDA), facilitating KL1333’s clinical development and path forward to market.
  • The goal of enrolling 40 patients for Wave 1 of the FALCON study was met in December. The interim analysis remains on track for summer of 2024.


  • The U.S. Patent and Trademark Office granted a composition of matter patent in February.
  • Orphan Drug Designation (ODD) was granted in April in the U.S. for the treatment of mitochondrial disease.
  • Orphan designation was granted by the European Commission in December for the treatment of Leigh syndrome.


  • Abliva appointed Dag Nesse as Vice President of Clinical Operations in February.
  • World Mitochondrial Disease Week, Septermber 18 – 24, was recognized by Abliva by the release of videos highlighting the ongoing activities at the company. The videos can be found at Abliva’s website www.abliva.com.
  • A licensing and collaboration agreement for Abliva’s NeuroSTAT®, for the treatment of moderate to severe traumatic brain injury (TBI), was signed by Abliva and Owl Therapeutics of San Antonio, Texas (US) in November. See page 17 for more information.

Important events after the reporting period

  • The Board of Directors of Abliva AB has on 22 February resolved on a capital raise totalling app. SEK 88 million through a fully guaranteed rights issue of app. SEK 46 million, and a directed issue of convertible bonds of app. SEK 42 million. The convertible loan amount shall be paid and immediately converted into shares in the Company after the announcement of the interim data from the KL 1333 Phase 2 study provided the results from the study is positive, i.e. non futile. The Transaction is conditional upon approval by an Extraordinary General Meeting intended to be held on March 26, 2024. For further information, see page 10.
  • Abliva convened an Extraordinary General Meeting to be held at 3 p.m. on Tuesday 26 March 2024 at Medicon Village, Scheeletorget 1, in Lund, Sweden, with admission for registration from 2.30 p.m.

Financial information

October-December 2023*

  • Net revenues: SEK 137,000 (0)
  • Other operating income: SEK 0 (1,504,000)
  • Loss before tax: SEK 25,258,000 (17,576,000)
  • Loss per share before dilution: SEK 0.02 (0.04)
  • Diluted loss per share: SEK 0.02 (0.04)

January-December 2023*

  • Net revenues: SEK 137,000 (31,000)
  • Other operating income: SEK 1,345,000 (1,716,000)
  • Loss before tax: SEK 95,518,000 (85,264,000)
  • Loss per share before dilution: SEK 0.09 (0.12)
  • Diluted loss per share: SEK 0.09 (0.12)

* APM Alternative performance measures, see definition on page 20.

The complete Interim report is available for download below and through Abliva’s website www.abliva.com.