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 .