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Beskrivning
Land | Sverige |
---|---|
Lista | Small Cap Stockholm |
Sektor | Hälsovård |
Industri | Bioteknik |
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.
For more information, please contact:
Catharina Johansson, Deputy CEO, CFO & VP Investor Relations
+46 (0)46-275 62 21, ir@abliva.com
Abliva AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard)
info@abliva.com, www.abliva.com
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Follow us on LinkedIn: https://www.linkedin.com/company/abliva
Subscribe to our YouTube channel: https://www.youtube.com/channel/UChqP7Ky5caXtp72CELhD6Mg
Abliva – Delivering mitochondrial health
Abliva discovers and develops medicines for the treatment of mitochondrial disease. This rare and often very severe disease occurs when the cell’s energy provider, the mitochondria, do not function properly. The company has prioritized two projects. KL1333, a powerful regulator of the essential co-enzymes NAD⁺ and NADH, has entered late-stage development. NV354, an energy replacement therapy, has completed preclinical development. Abliva, based in Lund, Sweden, is listed on Nasdaq Stockholm, Sweden (ticker: ABLI).