Abliva AB Interim Report January – September 2023

KL1333 Received FDA Fast Track Designation | The FALCON Study Reached an Important Milestone

Third quarter summary

Important events third quarter (Jul – Sep 2023)

  • Fast Track designation was received for Abliva’s lead drug candidate KL1333 from the U.S. Food and Drug Administration (FDA), facilitating its clinical development and path forward to market.
  • World Mitochondrial Disease Week 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.

Important events after the reporting period

  • The target number of patients required for screening was reached in Wave 1 of the FALCON study with lead candidate KL1333. The study continues as planned and the interim analysis is expected towards the middle of 2024.
  • 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).

Financial information

July-September 2023*

  • Net revenues: SEK 0 (31,000)
  • Other operating income: SEK 0 (651,000)
  • Loss before tax: SEK 32,942,000 (25,124,000)
  • Loss per share before dilution: SEK 0.03 (0.04)
  • Diluted loss per share: SEK 0.03 (0.04)

January-September 2023*

  • Net revenues: SEK 0 (31,000)
  • Other operating income: SEK 2,783,000 (212,000)
  • Loss before tax: SEK 70,260,000 (67,688,000)
  • Loss per share before dilution: SEK 0.07 (0.11)
  • Diluted loss per share: SEK 0.07 (0.11)

* 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.